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f960b0d45a0b4ade0630eb1df8c4dec1	104 169	1 Scope	The present document provides a mapping between the Critical Security Controls and DORA provisions.
f960b0d45a0b4ade0630eb1df8c4dec1	104 169	2 References
f960b0d45a0b4ade0630eb1df8c4dec1	104 169	2.1 Normative references	Normative references are not applicable in the present document.
f960b0d45a0b4ade0630eb1df8c4dec1	104 169	2.2 Informative references	References are either specific (identified by date of publication and/or edition number or version number) or non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the referenced document (including any amendments) applies. NOTE: While any hyperlinks included in this clause were valid at the time of publication ETSI cannot guarantee their long-term validity. The following referenced documents may be useful in implementing an ETSI deliverable or add to the reader's understanding, but are not required for conformance to the present document. [i.1] Regulation (EU) 2022/2554 of the European Parliament and of the Council of 14 December 2022 on digital operational resilience for the financial sector and amending Regulations (EC) No 1060/2009, (EU) No 648/2012, (EU) No 600/2014, (EU) No 909/2014 and (EU) 2016/1011. [i.2] Directive (EU) 2022/2555 of the European Parliament and of the Council of 14 December 2022 on measures for a high common level of cybersecurity across the Union, amending Regulation (EU) No 910/2014 and Directive (EU) 2018/1972, and repealing Directive (EU) 2016/1148 (NIS 2 Directive). [i.3] 2020/0266 (COD), COM(2020) 595 final: "Proposal for a Regulation of the European Parliament and of the Council on digital operational resilience for the financial sector and amending Regulations (EC) No 1060/2009, (EU) No 648/2012, (EU) No 600/2014 and (EU) No 909/2014". [i.4] Directive (EU) 2022/2557 of the European Parliament and of the Council of 14 December 2022 on the resilience of critical entities and repealing Council Directive 2008/114/EC. [i.5] Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act). [i.6] Council Directive 2008/114/EC of 8 December 2008 on the identification and designation of European critical infrastructures and the assessment of the need to improve their protection. [i.7] Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act). [i.8] Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). [i.9] Center for Internet Security: "CIS Controls v8.1 Mapping to DORA". [i.10] ETSI TS 103 305-1: "Cyber Security (CYBER); Critical Security Controls for Effective Cyber Defence; Part 1: The Critical Security Controls". [i.11] ETSI TR 103 305-4: "Cyber Security (CYBER); Critical Security Controls for Effective Cyber Defence; Part 4: Facilitation Mechanisms". ETSI ETSI TR 104 169 V1.1.1 (2025-09) 6 [i.12] ETSI TR 103 305-5: "Cyber Security (CYBER); Critical Security Controls for Effective Cyber Defence; Part 5: Privacy and personal data protection enhancement". [i.13] ETSI TR 103 866: "Cyber Security (CYBER); Implementation of the Revised Network and Information Security (NIS2) Directive applying Critical Security Controls". [i.14] ETSI TS 103 960: "Cyber Security (CYBER); Implementation of the Digital Operational Resilience Act (DORA)". [i.15] NIST CSF PR.DS-7: "The development and testing environment(s) are separate from the production environment". [i.16] NIST CSF PR.DS-3: "Assets are formally managed throughout removal, transfers, and disposition".
f960b0d45a0b4ade0630eb1df8c4dec1	104 169	3 Definition of terms, symbols and abbreviations
f960b0d45a0b4ade0630eb1df8c4dec1	104 169	3.1 Terms	Void.
f960b0d45a0b4ade0630eb1df8c4dec1	104 169	3.2 Symbols	Void.
f960b0d45a0b4ade0630eb1df8c4dec1	104 169	3.3 Abbreviations	For the purposes of the present document, the following abbreviations apply: AAA Authentication, Authorization, and Accounting COTS Commercial Off The Shelf CSC Critical Security Controls CSF Computer Security Framework DHCP Dynamic Host Configuration Protocol DORA Digital Operational Resilience Act ERM Enterprise Risk Management IG1 Implementation Group 1 IG2 Implementation Group 2 IG3 Implementation Group 3 SSO Single Sign-On ETSI ETSI TR 104 169 V1.1.1 (2025-09) 7 4 Applying the Critical Security Controls for effective implementation of DORA
f960b0d45a0b4ade0630eb1df8c4dec1	104 169	4.1 Methodology and use	Methodology The methodology used to create the mapping can be useful to anyone attempting to understand the relationships between the Critical Security Controls and DORA. The overall goal for Control mappings is to be as specific as possible, leaning towards under-mapping versus over-mapping. The general strategy used is to identify all of the aspects within a control and attempt to discern if both items state the same thing. For instance: Control 6.1 - Establish an Access Granting Process Establish and follow a process, preferably automated, for granting access to enterprise assets upon new hire, rights grant, or role change of a user. For a defensive mitigation to map to this CSC Safeguard it is required by DORA to have at least one of the following: • A clearly documented process, covering both new employees and changes in access. • All relevant enterprise access control is required by DORA to be covered under this process, there can be no separation where different teams control access to different assets. • Automated tools are ideally used, such as a SSO provider or routing access control through a directory service. • The same process is followed every time a user's rights change, so a user never amasses greater rights access without documentation. If the two concepts are effectively equal, they are mapped with the relationship "equivalent". If they are not equal but still related, the exact type of relationship between two defensive mitigations can be further explored. The relationships can be further analysed to understand how similar or different the two defensive mitigations are. The relationship column will contain one of four possible values: • Equivalent: The defensive mitigation contains the exact same security concept as the Control. • Superset: The Control is partially or mostly related to the defensive mitigation in question, but the Control is broader in concept. • Subset: The Safeguard is partially or mostly related yet is still subsumed within the defensive mitigation. The defensive mitigation in question is broader in concept than the Control. • No relationship: This will be represented by a blank cell. The relationships should be read from left to right, like a sentence. Control Safeguard X is Equivalent to this < >. EXAMPLES: • Safeguard 16.8 "Separate Production and Non-Production Systems" is equivalent to NIST CSF PR.DS-7 [i.15]. • Safeguard 3.5 "Securely Dispose of Data" is a subset of NIST CSF PR.DS-3 [i.16]. The Critical Security Controls are written with certain principles in mind, such as only having one ask per Safeguard. This means many of the mapping targets are written in a way that contain multiple Safeguards within the same defensive mitigation, so the relationship can often be "Subset". Mappings are available from a variety of sources online, and different individuals may make their own decisions on the type of relationship. Critical Security Controls mappings are intended to be as objective as possible, and improvements are encouraged. ETSI ETSI TR 104 169 V1.1.1 (2025-09) 8 Use The clauses in the Critical Security Controls [i.10] concerning delineation of Asset Types, Security Functions, and Implementation Groups apply to the mappings below. For reference, these delineations are repeated in part here. Asset Types are shown in Figure 4.1-1. Figure 4.1-1 Security Functions include: • GOVERN - The organization's cybersecurity risk management strategy, expectations, and policy are established, communicated, and monitored. The GOVERN Function provides outcomes to inform what an organization may do to achieve and prioritize the outcomes of the other five Functions in the context of its mission and stakeholder expectations. Governance activities are critical for incorporating cybersecurity into an organization's broader Enterprise Risk Management (ERM) strategy. GOVERN addresses an understanding of organizational context; the establishment of cybersecurity strategy and cybersecurity supply chain risk management; roles, responsibilities, and authorities; policy; and the oversight of cybersecurity strategy. • IDENTIFY - The organization's current cybersecurity risks are understood. Understanding the organization's assets (e.g. data, hardware, software, systems, facilities, services, people), suppliers, and related cybersecurity risks enables an organization to prioritize its efforts consistent with its risk management strategy and the mission needs identified under GOVERN. This Function also includes the identification of improvement opportunities for the organization's policies, plans, processes, procedures, and practices that support cybersecurity risk management to inform efforts under all six Functions. • PROTECT - Safeguards to manage the organization's cybersecurity risks are used. Once assets and risks are identified and prioritized, PROTECT supports the ability to secure those assets to prevent or lower the likelihood and impact of adverse cybersecurity events, as well as to increase the likelihood and impact of taking advantage of opportunities. Outcomes covered by this Function include identity management, authentication, and access control; awareness and training; data security; platform security (i.e. securing the hardware, software, and services of physical and virtual platforms); and the resilience of technology infrastructure. ETSI ETSI TR 104 169 V1.1.1 (2025-09) 9 • DETECT - Possible cybersecurity attacks and compromises are found and analysed. DETECT enables the timely discovery and analysis of anomalies, indicators of compromise, and other potentially adverse events that may indicate that cybersecurity attacks and incidents are occurring. This Function supports successful incident response and recovery activities. • RESPOND - Actions regarding a detected cybersecurity incident are taken. RESPOND supports the ability to contain the effects of cybersecurity incidents. Outcomes within this Function cover incident management, analysis, mitigation, reporting, and communication. • RECOVER - Assets and operations affected by a cybersecurity incident are restored. RECOVER supports the timely restoration of normal operations to reduce the effects of cybersecurity incidents and enable appropriate communication during recovery efforts. Implementation Groups include: • IG1. An IG1 enterprise is small to medium-sized with limited IT and cybersecurity expertise to dedicate toward protecting IT assets and personnel. The principal concern of these enterprises is to keep the business operational, as they have a limited tolerance for downtime. The sensitivity of the data that they are trying to protect is low and principally surrounds employee and financial information. Safeguards selected for IG1 should be implementable with limited cybersecurity expertise and aimed to thwart general, non-targeted attacks. These Safeguards will also typically be designed to work in conjunction with small or home office Commercial Off-The-Shelf (COTS) hardware and software. • IG2 (Includes IG1). An IG2 enterprise employs individuals responsible for managing and protecting IT infrastructure. These enterprises support multiple departments with differing risk profiles based on job function and mission. Small enterprise units can have regulatory compliance burdens. IG2 enterprises often store and process sensitive client or enterprise information and can withstand short interruptions of service. A major concern is loss of public confidence if a breach occurs. Safeguards selected for IG2 help security teams cope with increased operational complexity. Some Safeguards will depend on enterprise-grade technology and specialized expertise to properly install and configure. • IG3 (Includes IG1 and IG2). An IG3 enterprise employs security experts that specialize in the different facets of cybersecurity (e.g. risk management, penetration testing, application security). IG3 assets and data contain sensitive information or functions that are subject to regulatory and compliance oversight. An IG3 enterprise is required by DORA to address availability of services and the confidentiality and integrity of sensitive data. Successful attacks can cause significant harm to the public welfare. Safeguards selected for IG3 is required by DORA to abate targeted attacks from a sophisticated adversary and reduce the impact of zero-day attacks.
f960b0d45a0b4ade0630eb1df8c4dec1	104 169	4.2 Applicability Overview	Table 4.2-1 below provides a mapping by the Critical Security Controls community to the DORA provisions to support the indicated requirements [i.9]. Table 4.2-1: Applicability of the Critical Security Controls to DORA Control Safeguard Title Applicability 1 Inventory and Control of Enterprise Assets 1 of 5 2 Inventory and Control of Software Assets 1 of 7 3 Data Protection 8 of 14 4 Secure Configuration of Enterprise Assets and Software 0 of 12 5 Account Management 0 of 6 6 Access Control Management 3 of 8 7 Continuous Vulnerability Management 2 of 9 8 Audit Log Management 0 of 12 9 Email and Web Browser Protections 0 of 7 10 Malware Defences 0 of 7 11 Data Recovery 4 of 5 12 Network Infrastructure Management 1 of 8 13 Network Monitoring and Defence 5 of 11 ETSI ETSI TR 104 169 V1.1.1 (2025-09) 10 Control Safeguard Title Applicability 14 Security Awareness and Skills Training 2 of 9 15 Service Provider Management 6 of 7 16 Application Software Security 0 of 14 17 Incident Response Management 7 of 9 18 Penetration Testing 0 of 5 ETSI ETSI TR 104 169 V1.1.1 (2025-09) 11
f960b0d45a0b4ade0630eb1df8c4dec1	104 169	4.3 Applying the Critical Security Controls and Safeguards	Table 4.3-1 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 1 Inventory and Control of Enterprise Assets 1.1 Devices Identify Establish and Maintain Detailed Enterprise Asset Inventory x x x Subset 8.1 Identification As part of the ICT risk management framework referred to in Article 6(1), financial entities shall identify, classify and adequately document all ICT supported business functions, roles and responsibilities, the information assets and ICT assets supporting those functions, and their roles and dependencies in relation to ICT risk. Financial entities shall review as needed, and at least yearly, the adequacy of this classification and of any relevant documentation. 1.1 Devices Identify Establish and Maintain Detailed Enterprise Asset Inventory x x x Subset 8.4 Identification Financial entities shall identify all information assets and ICT assets, including those on remote sites, network resources and hardware equipment, and shall map those considered critical. They shall map the configuration of the information assets and ICT assets and the links and interdependencies between the different information assets and ICT assets. 1.1 Devices Identify Establish and Maintain Detailed Enterprise Asset Inventory x x x Subset 8.6 Identification For the purposes of paragraphs 1, 4 and 5, financial entities shall maintain relevant inventories and update them periodically and every time any major change as referred to in paragraph 3 occurs. 1.2 Devices Respond Address Unauthorized Assets x x x 1.3 Devices Detect Utilize an Active Discovery Tool x x ETSI ETSI TR 104 169 V1.1.1 (2025-09) 12 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 1.4 Devices Identify Use Dynamic Host Configuration Protocol (DHCP) Logging to Update Enterprise Asset Inventory x x 1.5 Devices Detect Use a Passive Asset Discovery Tool x 2 Inventory and Control of Software Assets 2.1 Software Identify Establish and Maintain a Software Inventory x x x Subset 8.1 Identification As part of the ICT risk management framework referred to in Article 6(1), financial entities shall identify, classify and adequately document all ICT supported business functions, roles and responsibilities, the information assets and ICT assets supporting those functions, and their roles and dependencies in relation to ICT risk. Financial entities shall review as needed, and at least yearly, the adequacy of this classification and of any relevant documentation. 2.1 Software Identify Establish and Maintain a Software Inventory x x x Subset 8.6 Identification For the purposes of paragraphs 1, 4 and 5, financial entities shall maintain relevant inventories and update them periodically and every time any major change as referred to in 3 occurs. 2.2 Software Identify Ensure Authorized Software is Currently Supported x x x 2.3 Software Respond Address Unauthorized Software x x x 2.4 Software Detect Utilize Automated Software Inventory Tools x x 2.5 Software Protect Allowlist Authorized Software x x 2.6 Software Protect Allowlist Authorized Libraries x x 2.7 Software Protect Allowlist Authorized Scripts x 3 Data Protection 3.1 Data Govern Establish and Maintain a Data Management Process x x x Subset 9.3, Point (d) Protection and Prevention Ensure that data is protected from risks arising from data management, including poor administration, processing-related risks and human error. ETSI ETSI TR 104 169 V1.1.1 (2025-09) 13 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 3.1 Data Govern Establish and Maintain a Data Management Process x x x Subset 9.4, Point (a) Protection and Prevention Develop and document an information security policy defining rules to protect the availability, authenticity, integrity and confidentiality of data, information assets and ICT assets, including those of their customers, where applicable. 3.2 Data Identify Establish and Maintain a Data Inventory x x x Subset 8.1 Identification As part of the ICT risk management framework referred to in Article 6(1), financial entities shall identify, classify and adequately document all ICT supported business functions, roles and responsibilities, the information assets and ICT assets supporting those functions, and their roles and dependencies in relation to ICT risk. Financial entities shall review as needed, and at least yearly, the adequacy of this classification and of any relevant documentation. 3.2 Data Identify Establish and Maintain a Data Inventory x x x Subset 8.6 Identification For the purposes of paragraphs 1, 4 and 5, financial entities shall maintain relevant inventories and update them periodically and every time any major change as referred to in 3 occurs. 3.3 Data Protect Configure Data Access Control Lists x x x 3.4 Data Protect Enforce Data Retention x x x 3.5 Data Protect Securely Dispose of Data x x x 3.6 Data Protect Encrypt Data on End-User Devices x x x 3.7 Data Identify Establish and Maintain a Data Classification Scheme x x Subset 9.4, Point (d) Protection and Prevention Implement policies and protocols for strong authentication mechanisms, based on relevant standards and dedicated control systems, and protection measures of cryptographic keys whereby data is encrypted based on results of approved data classification and ICT risk assessment processes. ETSI ETSI TR 104 169 V1.1.1 (2025-09) 14 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 3.8 Data Identify Document Data Flows x x Subset 8.4 Identification Financial entities shall identify all information assets and ICT assets, including those on remote sites, network resources and hardware equipment, and shall map those considered critical. They shall map the configuration of the information assets and ICT assets and the links and interdependencies between the different information assets and ICT assets. 3.8 Data Identify Document Data Flows x x Subset 8.6 Identification For the purposes of paragraphs 1, 4 and 5, financial entities shall maintain relevant inventories and update them periodically and every time any major change as referred to in 3 occurs. 3.9 Data Protect Encrypt Data on Removable Media x x 3.10 Data Protect Encrypt Sensitive Data in Transit x x Subset 9.3, Point (a) Protection and Prevention Ensure the security of the means of transfer of data. 3.11 Data Protect Encrypt Sensitive Data at Rest x x Subset 9.3, Point (b) Protection and Prevention Minimize the risk of corruption or loss of data, unauthorized access and technical flaws that may hinder business activity. 3.12 Data Protect Segment Data Processing and Storage Based on Sensitivity x x Subset 9.4, Point (b) Protection and Prevention Following a risk-based approach, establish a sound network and infrastructure management structure using appropriate techniques, methods and protocols that may include implementing automated mechanisms to isolate affected information assets in the event of cyber-attacks. 3.13 Data Protect Deploy a Data Loss Prevention Solution x Subset 9.3, Point (b) Protection and Prevention Minimize the risk of corruption or loss of data, unauthorized access and technical flaws that may hinder business activity. 3.13 Data Protect Deploy a Data Loss Prevention Solution x Subset 9.3, Point (c) Protection and Prevention Prevent the lack of availability, the impairment of the authenticity and integrity, the breaches of confidentiality and the loss of data. 3.14 Data Detect Log Sensitive Data Access x ETSI ETSI TR 104 169 V1.1.1 (2025-09) 15 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 4 Secure Configuration of Enterprise Assets and Software 4.1 Documentation Govern Establish and Maintain a Secure Configuration Process x x x 4.2 Documentation Govern Establish and Maintain a Secure Configuration Process for Network Infrastructure x x x 4.3 Devices Protect Configure Automatic Session Locking on Enterprise Assets x x x 4.4 Devices Protect Implement and Manage a Firewall on Servers x x x 4.5 Devices Protect Implement and Manage a Firewall on End-User Devices x x x 4.6 Devices Protect Securely Manage Enterprise Assets and Software x x x 4.7 Users Protect Manage Default Accounts on Enterprise Assets and Software x x x 4.8 Devices Protect Uninstall or Disable Unnecessary Services on Enterprise Assets and Software x x 4.9 Devices Protect Configure Trusted DNS Servers on Enterprise Assets x x 4.10 Devices Protect Enforce Automatic Device Lockout on Portable End- User Devices x x 4.11 Data Protect Enforce Remote Wipe Capability on Portable End-User Devices x x 4.12 Data Protect Separate Enterprise Workspaces on Mobile End-User Devices x ETSI ETSI TR 104 169 V1.1.1 (2025-09) 16 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 5 Account Management 5.1 Users Identify Establish and Maintain an Inventory of Accounts x x x 5.2 Users Protect Use Unique Passwords x x x 5.3 Users Protect Disable Dormant Accounts x x x 5.4 Users Protect Restrict Administrator Privileges to Dedicated Administrator Accounts x x x 5.5 Users Identify Establish and Maintain an Inventory of Service Accounts x x 5.6 Users Protect Centralize Account Management x x 6 Access Control Management 6.1 Documentation Govern Establish an Access Granting Process x x x 6.2 Documentation Govern Establish an Access Revoking Process x x x 6.3 Users Protect Require MFA for Externally- Exposed Applications x x x 6.4 Users Protect Require MFA for Remote Network Access x x x 6.5 Users Protect Require MFA for Administrative Access x x x 6.6 Software Identify Establish and Maintain an Inventory of Authentication and Authorization Systems x x Subset 9.4, Point (d) Protection and Prevention Implement policies and protocols for strong authentication mechanisms, based on relevant standards and dedicated control systems, and protection measures of cryptographic keys whereby data is encrypted based on results of approved data classification and ICT risk assessment processes. 6.7 Users Protect Centralize Access Control x x Subset 9.4, Point (d) Protection and Prevention Implement policies and protocols for strong authentication mechanisms, based on relevant standards and dedicated control systems, and protection measures of cryptographic keys whereby data is encrypted based on results of approved data classification and ICT risk assessment processes. ETSI ETSI TR 104 169 V1.1.1 (2025-09) 17 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 6.8 Users Govern Define and Maintain Role-Based Access Control x Subset 5.2, Point (c) Governance and Organization Set clear roles and responsibilities for all ICT-related functions and establish appropriate governance arrangements to ensure effective and timely communication, cooperation and coordination among those functions. 6.8 Users Govern Define and Maintain Role-Based Access Control x Subset 8.1 Identification As part of the ICT risk management framework referred to in Article 6(1), financial entities shall identify, classify and adequately document all ICT supported business functions, roles and responsibilities, the information assets and ICT assets supporting those functions, and their roles and dependencies in relation to ICT risk. Financial entities shall review as needed, and at least yearly, the adequacy of this classification and of any relevant documentation. 6.8 Users Govern Define and Maintain Role-Based Access Control x Subset 8.6 Identification For the purposes of paragraphs 1, 4 and 5, financial entities shall maintain relevant inventories and update them periodically and every time any major change as referred to in 3 occurs. 6.8 Users Govern Define and Maintain Role-Based Access Control x Subset 9.4, Point (c) Protection and Prevention Implement policies that limit the physical or logical access to information assets and ICT assets to what is required for legitimate and approved functions and activities only, and establish to that end a set of policies, procedures and controls that address access rights and ensure a sound administration thereof. ETSI ETSI TR 104 169 V1.1.1 (2025-09) 18 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 7 Continuous Vulnerability Management 7.1 Documentation Govern Establish and Maintain a Vulnerability Management Process x x x Subset 9.1 Protection and Prevention For the purposes of adequately protecting ICT systems and with a view to organizing response measures, financial entities shall continuously monitor and control the security and functioning of ICT systems and tools and shall minimize the impact of ICT risk on ICT systems through the deployment of appropriate ICT security tools, policies and procedures. 7.1 Documentation Govern Establish and Maintain a Vulnerability Management Process x x x Subset 9.4, Point (f) Protection and Prevention Have appropriate and comprehensive documented policies for patches and updates. 7.1 Documentation Govern Establish and Maintain a Vulnerability Management Process x x x Subset 16.1, Point (c) Simplified ICT Risk Management Framework Minimize the impact of ICT risk through the use of sound, resilient and updated ICT systems, protocols and tools which are appropriate to support the performance of their activities and the provision of services and adequately protect availability, authenticity, integrity and confidentiality of data in the network and information systems. 7.1 Documentation Govern Establish and Maintain a Vulnerability Management Process x x x Subset 16.1, Point (d) Simplified ICT Risk Management Framework Allow sources of ICT risk and anomalies in the network and information systems to be promptly identified and detected and ICT-related incidents to be swiftly handled. 7.2 Documentation Govern Establish and Maintain a Remediation Process x x x Subset 9.4, Point (f) Protection and Prevention Have appropriate and comprehensive documented policies for patches and updates. 7.3 Software Protect Perform Automated Operating System Patch Management x x x 7.4 Software Protect Perform Automated Application Patch Management x x x 7.5 Software Identify Perform Automated Vulnerability Scans of Internal Enterprise Assets x x ETSI ETSI TR 104 169 V1.1.1 (2025-09) 19 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 7.6 Software Identify Perform Automated Vulnerability Scans of Externally-Exposed Enterprise Assets x x 7.7 Software Respond Remediate Detected Vulnerabilities x x 8 Audit Log Management 8.1 Documentation Govern Establish and Maintain an Audit Log Management Process x x x 8.2 Data Detect Collect Audit Logs x x x 8.3 Data Protect Ensure Adequate Audit Log Storage x x x 8.4 Network Protect Standardize Time Synchronization x x 8.5 Data Detect Collect Detailed Audit Logs x x 8.6 Data Detect Collect DNS Query Audit Logs x x 8.7 Data Detect Collect URL Request Audit Logs x x 8.8 Data Detect Collect Command-Line Audit Logs x x 8.9 Data Detect Centralize Audit Logs x x 8.10 Data Protect Retain Audit Logs x x 8.11 Data Detect Conduct Audit Log Reviews x x 8.12 Data Detect Collect Service Provider Logs x 9 Email and Web Browser Protections 9.1 Software Protect Ensure Use of Only Fully Supported Browsers and Email Clients x x x 9.2 Devices Protect Use DNS Filtering Services x x x 9.3 Network Protect Maintain and Enforce Network-Based URL Filters x x 9.4 Software Protect Restrict Unnecessary or Unauthorized Browser and Email Client Extensions x x ETSI ETSI TR 104 169 V1.1.1 (2025-09) 20 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 9.5 Network Protect Implement DMARC x x 9.6 Network Protect Block Unnecessary File Types x x 9.7 Network Protect Deploy and Maintain Email Server Anti-Malware Protections x 10 Malware Defenses 10.1 Devices Detect Deploy and Maintain Anti- Malware Software x x x 10.2 Devices Protect Configure Automatic Anti- Malware Signature Updates x x x 10.3 Devices Protect Disable Autorun and Autoplay for Removable Media x x x 10.4 Devices Detect Configure Automatic Anti- Malware Scanning of Removable Media x x 10.5 Devices Protect Enable Anti-Exploitation Features x x 10.6 Devices Protect Centrally Manage Anti- Malware Software x x 10.7 Devices Detect Use Behaviour-Based Anti- Malware Software x x 11 Data Recovery 11.1 Documentation Govern Establish and Maintain a Data Recovery Process x x x Equivalent 12.1, Point (a) Backup and Restoration Backup policies and procedures specifying the scope of the data that is subject to the backup and the minimum frequency of the backup, based on the criticality of information or the confidentiality level of the data. 11.1 Documentation Govern Establish and Maintain a Data Recovery Process x x x Superset 12.1, Point (b) Backup and Restoration Restoration and recovery procedures and methods. ETSI ETSI TR 104 169 V1.1.1 (2025-09) 21 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 11.1 Documentation Govern Establish and Maintain a Data Recovery Process x x x Superset 12.2 Backup and Restoration Financial entities shall set up backup systems that can be activated in accordance with the backup policies and procedures, as well as restoration and recovery procedures and methods. The activation of backup systems shall not jeopardize the security of the network and information systems or the availability, authenticity, integrity or confidentiality of data. Testing of the backup procedures and restoration and recovery procedures and methods shall be undertaken periodically. 11.1 Documentation Govern Establish and Maintain a Data Recovery Process x x x Superset 16.1, Point (f) Simplified ICT Risk Management Framework Ensure the continuity of critical or important functions, through business continuity plans and response and recovery measures, which include, at least, back-up and restoration measures. 11.2 Data Recover Perform Automated Backups x x x 11.3 Data Protect Protect Recovery Data x x x Subset 12.7 Backup and Restoration When recovering from an ICT-related incident, financial entities shall perform necessary checks, including any multiple checks and reconciliations, in order to ensure that the highest level of data integrity is maintained. These checks shall also be performed when reconstructing data from external stakeholders, in order to ensure that all data is consistent between systems. ETSI ETSI TR 104 169 V1.1.1 (2025-09) 22 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 11.4 Data Recover Establish and Maintain an Isolated Instance of Recovery Data x x x Subset 12.3 Backup and Restoration When restoring backup data using own systems, financial entities shall use ICT systems that are physically and logically segregated from the source ICT system. The ICT systems shall be securely protected from any unauthorized access or ICT corruption and allow for the timely restoration of services making use of data and system backups as necessary. For central counterparties, the recovery plans shall enable the recovery of all transactions at the time of disruption to allow the central counterparty to continue to operate with certainty and to complete settlement on the scheduled date. Data reporting service providers shall additionally maintain adequate resources and have back-up and restoration facilities in place in order to offer and maintain their services at all times. 11.5 Data Recover Test Data Recovery x x Subset 12.2 Backup and Restoration Financial entities shall set up backup systems that can be activated in accordance with the backup policies and procedures, as well as restoration and recovery procedures and methods. The activation of backup systems shall not jeopardize the security of the network and information systems or the availability, authenticity, integrity or confidentiality of data. Testing of the backup procedures and restoration and recovery procedures and methods shall be undertaken periodically. 11.5 Data Recover Test Data Recovery x x Subset 16.1, Point (g) Simplified ICT Risk Management Framework Test, on a regular basis, the plans and measures referred to in point (f), as well as the effectiveness of the controls implemented in accordance with points (a) and (c). ETSI ETSI TR 104 169 V1.1.1 (2025-09) 23 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 12 Network Infrastructure Management 12.1 Network Protect Ensure Network Infrastructure is Up-to-Date x x x 12.2 Network Protect Establish and Maintain a Secure Network Architecture x x Subset 5.2, Point (b) Governance and Organization Put in place policies that aim to ensure the maintenance of high standards of availability, authenticity, integrity and confidentiality, of data. 12.2 Network Protect Establish and Maintain a Secure Network Architecture x x Subset 9.4, Point (b) Protection and Prevention Following a risk-based approach, establish a sound network and infrastructure management structure using appropriate techniques, methods and protocols that may include implementing automated mechanisms to isolate affected information assets in the event of cyber-attacks. 12.3 Network Protect Securely Manage Network Infrastructure x x 12.4 Documentation Govern Establish and Maintain Architecture Diagram(s) x x 12.5 Network Protect Centralize Network Authentication, Authorization, and Auditing (AAA) x x 12.6 Network Protect Use of Secure Network Management and Communication Protocols x x 12.7 Devices Protect Ensure Remote Devices Utilize a VPN and are Connecting to an Enterprise's AAA Infrastructure x x 12.8 Devices Protect Establish and Maintain Dedicated Computing Resources for All Administrative Work x ETSI ETSI TR 104 169 V1.1.1 (2025-09) 24 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 13 Network Monitoring and Defense 13.1 Network Detect Centralize Security Event Alerting x x Subset 10.1 Detection Financial entities shall have in place mechanisms to promptly detect anomalous activities, in accordance with Article 17, including ICT network performance issues and ICT-related incidents, and to identify potential material single points of failure. All detection mechanisms referred to in the first subparagraph shall be regularly tested in accordance with Article 25. 13.1 Network Detect Centralize Security Event Alerting x x Subset 16.1, Point (b) Simplified ICT Risk Management Framework Continuously monitor the security and functioning of all ICT systems. 13.2 Devices Detect Deploy a Host-Based Intrusion Detection Solution x x Subset 9.1 Protection and Prevention For the purposes of adequately protecting ICT systems and with a view to organizing response measures, financial entities shall continuously monitor and control the security and functioning of ICT systems and tools and shall minimize the impact of ICT risk on ICT systems through the deployment of appropriate ICT security tools, policies and procedures. 13.2 Devices Detect Deploy a Host-Based Intrusion Detection Solution x x Subset 10.1 Detection Financial entities shall have in place mechanisms to promptly detect anomalous activities, in accordance with Article 17, including ICT network performance issues and ICT-related incidents, and to identify potential material single points of failure. All detection mechanisms referred to in the first subparagraph shall be regularly tested in accordance with Article 25. ETSI ETSI TR 104 169 V1.1.1 (2025-09) 25 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 13.2 Devices Detect Deploy a Host-Based Intrusion Detection Solution x x Subset 10.3 Detection Financial entities shall devote sufficient resources and capabilities to monitor user activity, the occurrence of ICT anomalies and ICT-related incidents, in particular cyber-attacks. 13.3 Network Detect Deploy a Network Intrusion Detection Solution x x Subset 10.1 Detection Financial entities shall have in place mechanisms to promptly detect anomalous activities, in accordance with Article 17, including ICT network performance issues and ICT-related incidents, and to identify potential material single points of failure. All detection mechanisms referred to in the first subparagraph shall be regularly tested in accordance with Article 25. 13.4 Network Protect Perform Traffic Filtering Between Network Segments x x 13.5 Devices Protect Manage Access Control for Remote Assets x x 13.6 Network Detect Collect Network Traffic Flow Logs x x Subset 10.2 Detection The detection mechanisms referred to in paragraph 1 shall enable multiple layers of control, define alert thresholds and criteria to trigger and initiate ICT-related incident response processes, including automatic alert mechanisms for relevant staff in charge of ICT-related incident response. 13.6 Network Detect Collect Network Traffic Flow Logs x x Subset 10.3 Detection Financial entities shall devote sufficient resources and capabilities to monitor user activity, the occurrence of ICT anomalies and ICT-related incidents, in particular cyber- attacks. 13.7 Devices Protect Deploy a Host-Based Intrusion Prevention Solution x 13.8 Network Protect Deploy a Network Intrusion Prevention Solution x 13.9 Network Protect Deploy Port-Level Access Control x 13.10 Network Protect Perform Application Layer Filtering x ETSI ETSI TR 104 169 V1.1.1 (2025-09) 26 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 13.11 Network Detect Tune Security Event Alerting Thresholds x Subset 10.2 Detection The detection mechanisms referred to in paragraph 1 shall enable multiple layers of control, define alert thresholds and criteria to trigger and initiate ICT-related incident response processes, including automatic alert mechanisms for relevant staff in charge of ICT-related incident response. 14 Security Awareness and Skills Training 14.1 Documentation Govern Establish and Maintain a Security Awareness Program x x x Superset 13.6 Learning and Evolving Financial entities shall develop ICT security awareness programmes and digital operational resilience training as compulsory modules in their staff training schemes. Those programmes and training shall be applicable to all employees and to senior management staff, and shall have a level of complexity commensurate to the remit of their functions. Where appropriate, financial entities shall also include ICT third-party service providers in their relevant training schemes in accordance with Article 30(2), point (i). 14.2 Users Protect Train Workforce Members to Recognize Social Engineering Attacks x x x 14.3 Users Protect Train Workforce Members on Authentication Best Practices x x x 14.4 Users Protect Train Workforce on Data Handling Best Practices x x x 14.5 Users Protect Train Workforce Members on Causes of Unintentional Data Exposure x x x 14.6 Users Protect Train Workforce Members on Recognizing and Reporting Security Incidents x x x 14.7 Users Protect Train Workforce on How to Identify and Report if Their Enterprise Assets are Missing Security Updates x x x ETSI ETSI TR 104 169 V1.1.1 (2025-09) 27 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 14.8 Users Protect Train Workforce on the Dangers of Connecting to and Transmitting Enterprise Data Over Insecure Networks x x x 14.9 Users Protect Conduct Role-Specific Security Awareness and Skills Training x x Superset 5.4 Governance and Organization Members of the management body of the financial entity shall actively keep up to date with sufficient knowledge and skills to understand and assess ICT risk and its impact on the operations of the financial entity, including by following specific training on a regular basis, commensurate to the ICT risk being managed. 15 Service Provider Management 15.1 Users Identify Establish and Maintain an Inventory of Service Providers x x x Subset 8.5 Identification Financial entities shall identify and document all processes that are dependent on ICT third- party service providers, and shall identify interconnections with ICT third-party service providers that provide services that support critical or important functions. 15.1 Users Identify Establish and Maintain an Inventory of Service Providers x x x Subset 8.6 Identification For the purposes of paragraphs 1, 4 and 5, financial entities shall maintain relevant inventories and update them periodically and every time any major change as referred to in paragraph 3 occurs. 15.2 Documentation Govern Establish and Maintain a Service Provider Management Policy x x Subset 5.2, Point (b) Governance and Organization put in place policies that aim to ensure the maintenance of high standards of availability, authenticity, integrity and confidentiality, of data. 15.2 Documentation Govern Establish and Maintain a Service Provider Management Policy x x Subset 5.2, Point (h) Governance and Organization Approve and periodically review the financial entity's policy on arrangements regarding the use of ICT services provided by ICT third-party service providers. Put in place, at corporate level, reporting channels enabling it to be duly informed of the following. ETSI ETSI TR 104 169 V1.1.1 (2025-09) 28 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 15.3 Users Govern Classify Service Providers x x Subset 8.5 Identification Financial entities shall identify and document all processes that are dependent on ICT third-party service providers, and shall identify interconnections with ICT third-party service providers that provide services that support critical or important functions. 15.3 Users Govern Classify Service Providers x x Subset 8.6 Identification For the purposes of paragraphs 1, 4 and 5, financial entities shall maintain relevant inventories and update them periodically and every time any major change as referred to in paragraph 3 occurs. 15.3 Users Govern Classify Service Providers x x Subset 16.1, Point (e) Simplified ICT Risk Management Framework Identify key dependencies on ICT third-party service providers. 15.4 Documentation Govern Ensure Service Provider Contracts Include Security Requirements x x Subset 5.2, Point (h), Subpoint (ii) Governance and Organization The potential impact of such changes on the critical or important functions subject to those arrangements, including a risk analysis summary to assess the impact of those changes, and at least major ICT-related incidents and their impact, as well as response, recovery and corrective measures. 15.4 Documentation Govern Ensure Service Provider Contracts Include Security Requirements x x Subset 10.4 Detection Data reporting service providers shall, in addition, have in place systems that can effectively check trade reports for completeness, identify omissions and obvious errors, and request re-transmission of those reports. 15.5 Users Govern Assess Service Providers x 15.6 Data Govern Monitor Service Providers x Subset 5.2, Point (h), Subpoint (ii) Governance and Organization Any relevant planned material changes regarding the ICT third-party service providers. ETSI ETSI TR 104 169 V1.1.1 (2025-09) 29 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 15.6 Data Govern Monitor Service Providers x Subset 5.3 Governance and Organization Financial entities, other than microenterprises, shall establish a role in order to monitor the arrangements concluded with ICT third-party service providers on the use of ICT services, or shall designate a member of senior management as responsible for overseeing the related risk exposure and relevant documentation. 15.7 Data Protect Securely Decommission Service Providers x Superset 5.2, Point (h), Subpoint (i) Governance and Organization Arrangements concluded with ICT third-party service providers on the use of ICT services. 16 Application Software Security 16.1 Documentation Govern Establish and Maintain a Secure Application Development Process x x 16.2 Documentation Govern Establish and Maintain a Process to Accept and Address Software Vulnerabilities x x 16.3 Software Protect Perform Root Cause Analysis on Security Vulnerabilities x x 16.4 Software Identify Establish and Manage an Inventory of Third-Party Software Components x x 16.5 Software Protect Use Up-to-Date and Trusted Third-Party Software Components x x 16.6 Documentation Govern Establish and Maintain a Severity Rating System and Process for Application Vulnerabilities x x 16.7 Software Protect Use Standard Hardening Configuration Templates for Application Infrastructure x x 16.8 Network Protect Separate Production and Non-Production Systems x x ETSI ETSI TR 104 169 V1.1.1 (2025-09) 30 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 16.9 Users Protect Train Developers in Application Security Concepts and Secure Coding x x 16.10 Software Protect Apply Secure Design Principles in Application Architectures x x 16.11 Software Protect Leverage Vetted Modules or Services for Application Security Components x x 16.12 Software Protect Implement Code-Level Security Checks x 16.13 Software Detect Conduct Application Penetration Testing x 16.14 Software Protect Conduct Threat Modelling x 17 Incident Response Management 17.1 Users Respond Designate Personnel to Manage Incident Handling x x x Subset 5.2, Point (c) Governance and Organization Set clear roles and responsibilities for all ICT-related functions and establish appropriate governance arrangements to ensure effective and timely communication, cooperation and coordination among those functions. 17.1 Users Respond Designate Personnel to Manage Incident Handling x x x Superset 14.3 Communication At least one person in the financial entity shall be tasked with implementing the communication strategy for ICT-related incidents and fulfil the public and media function for that purpose. 17.1 Users Respond Designate Personnel to Manage Incident Handling x x x Superset 17.3, Point (c) ICT-related incident management process Assign roles and responsibilities that need to be activated for different ICT-related incident types and scenarios. 17.2 Documentation Govern Establish and Maintain Contact Information for Reporting Security Incidents x x x Subset 11.2, Point (e) Response and Recovery Set out communication and crisis management actions that ensure that updated information is transmitted to all relevant internal staff and external stakeholders in accordance with Article 14, and report to the competent authorities in accordance with Article 19. ETSI ETSI TR 104 169 V1.1.1 (2025-09) 31 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 17.2 Documentation Govern Establish and Maintain Contact Information for Reporting Security Incidents x x x Subset 14.1 Communication As part of the ICT risk management framework referred to in Article 6(1), financial entities shall have in place crisis communication plans enabling a responsible disclosure of, at least, major ICT-related incidents or vulnerabilities to clients and counterparts as well as to the public, as appropriate. 17.2 Documentation Govern Establish and Maintain Contact Information for Reporting Security Incidents x x x Subset 17.3, Point (d) ICT-related incident management process Set out plans for communication to staff, external stakeholders and media in accordance with Article 14 and for notification to clients, for internal escalation procedures, including ICT-related customer complaints, as well as for the provision of information to financial entities that act as counterparts, as appropriate. 17.2 Documentation Govern Establish and Maintain Contact Information for Reporting Security Incidents x x x Subset 17.3, Point (e) ICT-related incident management process Ensure that at least major ICT-related incidents are reported to relevant senior management and inform the management body of at least major ICT-related incidents, explaining the impact, response and additional controls to be established as a result of such ICT-related incidents. 17.2 Documentation Govern Establish and Maintain Contact Information for Reporting Security Incidents x x x Subset 19.1 Reporting of major ICT- related incidents and voluntary notification of significant cyber threats Financial entities shall report major ICT- related incidents to the relevant competent authority as referred to in Article 46 in accordance with paragraph 4 of this Article. 17.3 Documentation Govern Establish and Maintain an Enterprise Process for Reporting Incidents x x x ETSI ETSI TR 104 169 V1.1.1 (2025-09) 32 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 17.4 Documentation Govern Establish and Maintain an Incident Response Process x x Subset 5.2, Point (e) Governance and Organization Approve, oversee and periodically review the implementation of the financial entity's ICT business continuity policy and ICT response and recovery plans, referred to, respectively, in Article 11(1) and (3), which may be adopted as a dedicated specific policy forming an integral part of the financial entity's overall business continuity policy and response and recovery plan. 17.4 Documentation Govern Establish and Maintain an Incident Response Process x x Subset 11.2, Point (b) Response and Recovery Quickly, appropriately and effectively respond to, and resolve, all ICT-related incidents in a way that limits damage and prioritizes the resumption of activities and recovery actions. 17.4 Documentation Govern Establish and Maintain an Incident Response Process x x Subset 11.2, Point (c) Response and Recovery Activate, without delay, dedicated plans that enable containment measures, processes and technologies suited to each type of ICT-related incident and prevent further damage, as well as tailored response and recovery procedures established in accordance with Article 12. 17.4 Documentation Govern Establish and Maintain an Incident Response Process x x Subset 16.1, Point (f) Simplified ICT Risk Management Framework Ensure the continuity of critical or important functions, through business continuity plans and response and recovery measures, which include, at least, back-up and restoration measures. 17.4 Documentation Govern Establish and Maintain an Incident Response Process x x Subset 17.1 ICT-related incident management process Financial entities shall define, establish and implement an ICT-related incident management process to detect, manage and notify ICT-related incidents. 17.4 Documentation Govern Establish and Maintain an Incident Response Process x x Subset 17.2 ICT-related incident management process Financial entities shall record all ICT-related incidents and significant cyber threats. Financial entities shall establish appropriate procedures and processes to ensure a consistent and integrated monitoring, handling and follow-up of ICT-related incidents, to ensure that root causes are identified, documented and addressed in order to prevent the occurrence of such incidents. ETSI ETSI TR 104 169 V1.1.1 (2025-09) 33 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 17.4 Documentation Govern Establish and Maintain an Incident Response Process x x Subset 17.3, Point (f) ICT-related incident management process Establish ICT-related incident response procedures to mitigate impacts and ensure that services become operational and secure in a timely manner. 17.5 Users Respond Assign Key Roles and Responsibilities x x 17.6 Users Respond Define Mechanisms for Communicating During Incident Response x x Subset 11.2, Point (e) Response and Recovery Set out communication and crisis management actions that ensure that updated information is transmitted to all relevant internal staff and external stakeholders in accordance with Article 14, and report to the competent authorities in accordance with Article 19. 17.6 Users Respond Define Mechanisms for Communicating During Incident Response x x Subset 11.6, Point (b) Response and Recovery Test the crisis communication plans established in accordance with Article 14. 17.6 Users Respond Define Mechanisms for Communicating During Incident Response x x Subset 11.7 Response and Recovery Financial entities, other than microenterprises, shall have a crisis management function, which, in the event of activation of their ICT business continuity plans or ICT response and recovery plans, shall, inter alia, set out clear procedures to manage internal and external crisis communications in accordance with Article 14. 17.7 Users Recover Conduct Routine Incident Response Exercises x x Subset 11.4 Response and Recovery Financial entities shall put in place, maintain and periodically test appropriate ICT business continuity plans, notably with regard to critical or important functions outsourced or contracted through arrangements with ICT third-party service providers. 17.7 Users Recover Conduct Routine Incident Response Exercises x x Subset 11.6, Point (a) Response and Recovery Test the ICT business continuity plans and the ICT response and recovery plans in relation to ICT systems supporting all functions at least yearly, as well as in the event of any substantive changes to ICT systems supporting critical or important functions. ETSI ETSI TR 104 169 V1.1.1 (2025-09) 34 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 17.7 Users Recover Conduct Routine Incident Response Exercises x x Subset 16.1, Point (g) Simplified ICT Risk Management Framework Test, on a regular basis, the plans and measures referred to in point (f), as well as the effectiveness of the controls implemented in accordance with points (a) and (c). 17.8 Users Recover Conduct Post-Incident Reviews x x Subset 13.1 Learning and Evolving Financial entities shall have in place capabilities and staff to gather information on vulnerabilities and cyber threats, ICT-related incidents, in particular cyber-attacks, and analyse the impact they are likely to have on their digital operational resilience. ETSI ETSI TR 104 169 V1.1.1 (2025-09) 35 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 17.8 Users Recover Conduct Post-Incident Reviews x x Subset 13.2 Learning and Evolving Financial entities shall put in place post ICT- related incident reviews after a major ICT- related incident disrupts their core activities, analysing the causes of disruption and identifying required improvements to the ICT operations or within the ICT business continuity policy referred to in Article 11. Financial entities, other than microenterprises, shall, upon request, communicate to the competent authorities, the changes that were implemented following post ICT-related incident reviews as referred to in the first subparagraph. The post ICT-related incident reviews referred to in the first subparagraph shall determine whether the established procedures were followed and the actions taken were effective, including in relation to the following: (a) the promptness in responding to security alerts and determining the impact of ICT-related incidents and their severity; (b) the quality and speed of performing a forensic analysis, where deemed appropriate; (c) the effectiveness of incident escalation within the financial entity; (d) the effectiveness of internal and external communication. ETSI ETSI TR 104 169 V1.1.1 (2025-09) 36 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 17.8 Users Recover Conduct Post-Incident Reviews x x Subset 13.3 Learning and Evolving Lessons derived from the digital operational resilience testing carried out in accordance with Articles 26 and 27 and from real life ICT-related incidents, in particular cyber-attacks, along with challenges faced upon the activation of ICT business continuity plans and ICT response and recovery plans, together with relevant information exchanged with counterparts and assessed during supervisory reviews, shall be duly incorporated on a continuous basis into the ICT risk assessment process. Those findings shall form the basis for appropriate reviews of relevant components of the ICT risk management framework referred to in Article 6(1). 17.9 Documentation Recover Establish and Maintain Security Incident Thresholds x Subset 10.2 Detection The detection mechanisms referred to in paragraph 1 shall enable multiple layers of control, define alert thresholds and criteria to trigger and initiate ICT-related incident response processes, including automatic alert mechanisms for relevant staff in charge of ICT-related incident response. 17.9 Documentation Recover Establish and Maintain Security Incident Thresholds x Superset 17.3, Point (a) ICT-related incident management process Put in place early warning indicators. 17.9 Documentation Recover Establish and Maintain Security Incident Thresholds x Superset 17.3, Point (b) ICT-related incident management process Establish procedures to identify, track, log, categorize and classify ICT-related incidents according to their priority and severity and according to the criticality of the services impacted, in accordance with the criteria set out in Article 18(1). 18 Penetration Testing 18.1 Documentation Govern Establish and Maintain a Penetration Testing Program x x 18.2 Network Detect Perform Periodic External Penetration Tests x x ETSI ETSI TR 104 169 V1.1.1 (2025-09) 37 CIS Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 DORA Relationship DORA Provision DORA Category DORA Requirement Description 18.3 Network Protect Remediate Penetration Test Findings x x 18.4 Network Protect Validate Security Measures x 18.5 Network Detect Perform Periodic Internal Penetration Tests x ETSI ETSI TR 104 169 V1.1.1 (2025-09) 38 Annex A: Unmapped DORA Provisions The following DORA provisions are NOT mapped to the Critical Security Controls Safeguards. Table A.1 DORA Requirement # DORA Provision 5.1 Governance and Organization 5.2 Governance and Organization 5.2(a) Governance and Organization 5.2(d) Governance and Organization 5.2(f) Governance and Organization 5.2(g) Governance and Organization 6.1 ICT Risk Management Framework 6.2 ICT Risk Management Framework 6.3 ICT Risk Management Framework 6.4 ICT Risk Management Framework 6.5 ICT Risk Management Framework 6.6 ICT Risk Management Framework 6.7 ICT Risk Management Framework 6.8 ICT Risk Management Framework 6.8(a) ICT Risk Management Framework 6.8(b) ICT Risk Management Framework 6.8(c) ICT Risk Management Framework 6.8(d) ICT Risk Management Framework 6.8(e) ICT Risk Management Framework 6.8(f) ICT Risk Management Framework 6.8(g) ICT Risk Management Framework 6.8(h) ICT Risk Management Framework 6.9 ICT Risk Management Framework 6.1 ICT Risk Management Framework 8.2 Identification 8.3 Identification 8.7 Identification 9.2 Protection and Prevention 9.3 Protection and Prevention 9.4 Protection and Prevention 9.4(e) Protection and Prevention 11.1 Response and Recovery 11.2 Response and Recovery 11.2(a) Response and Recovery 11.2(d) Response and Recovery 11.3 Response and Recovery 11.5 Response and Recovery 11.6 Response and Recovery 11.8 Response and Recovery 11.9 Response and Recovery 11.1 Response and Recovery 11.11 Response and Recovery 12.1 Backup and Restoration 12.4 Backup and Restoration 12.5 Backup and Restoration 12.5(a) Backup and Restoration 12.5(b) Backup and Restoration 12.5(c) Backup and Restoration 12.6 Backup and Restoration 13.4 Learning and Evolving 13.5 Learning and Evolving 13.7 Learning and Evolving 14.2 Communication ETSI ETSI TR 104 169 V1.1.1 (2025-09) 39 DORA Requirement # DORA Provision 16.1(a) Simplified ICT Risk Management Framework 16.1(h) Simplified ICT Risk Management Framework 16.2 Simplified ICT Risk Management Framework 17.3 ICT-related incident management process ETSI ETSI TR 104 169 V1.1.1 (2025-09) 40 Annex B: Unmapped Critical Security Control Safeguards The following Critical Security Controls Safeguards are NOT mapping to DORA requirements. Table B.1 Safeguard Safeguard Name 1.2 Address Unauthorized Assets 1.3 Utilize an Active Discovery Tool 1.4 Use Dynamic Host Configuration Protocol (DHCP) Logging to Update Enterprise Asset Inventory 1.5 Use a Passive Asset Discovery Tool 2.2 Ensure Authorized Software is Currently Supported 2.3 Address Unauthorized Software 2.4 Utilize Automated Software Inventory Tools 2.5 Allowlist Authorized Software 2.6 Allowlist Authorized Libraries 2.7 Allowlist Authorized Scripts 3.3 Configure Data Access Control Lists 3.4 Enforce Data Retention 3.5 Securely Dispose of Data 3.6 Encrypt Data on End-User Devices 3.9 Encrypt Data on Removable Media 3.14 Log Sensitive Data Access 4.1 Establish and Maintain a Secure Configuration Process 4.2 Establish and Maintain a Secure Configuration Process for Network Infrastructure 4.3 Configure Automatic Session Locking on Enterprise Assets 4.4 Implement and Manage a Firewall on Servers 4.5 Implement and Manage a Firewall on End-User Devices 4.6 Securely Manage Enterprise Assets and Software 4.7 Manage Default Accounts on Enterprise Assets and Software 4.8 Uninstall or Disable Unnecessary Services on Enterprise Assets and Software 4.9 Configure Trusted DNS Servers on Enterprise Assets 4.1 Enforce Automatic Device Lockout on Portable End-User Devices 4.11 Enforce Remote Wipe Capability on Portable End-User Devices 4.12 Separate Enterprise Workspaces on Mobile End-User Devices 5.1 Establish and Maintain an Inventory of Accounts 5.2 Use Unique Passwords 5.3 Disable Dormant Accounts 5.4 Restrict Administrator Privileges to Dedicated Administrator Accounts 5.5 Establish and Maintain an Inventory of Service Accounts 5.6 Centralize Account Management 6.1 Establish an Access Granting Process 6.2 Establish an Access Revoking Process 6.3 Require MFA for Externally-Exposed Applications 6.4 Require MFA for Remote Network Access 6.5 Require MFA for Administrative Access 7.3 Perform Automated Operating System Patch Management 7.4 Perform Automated Application Patch Management 7.5 Perform Automated Vulnerability Scans of Internal Enterprise Assets 7.6 Perform Automated Vulnerability Scans of Externally-Exposed Enterprise Assets 7.7 Remediate Detected Vulnerabilities 8.1 Establish and Maintain an Audit Log Management Process 8.2 Collect Audit Logs 8.3 Ensure Adequate Audit Log Storage 8.4 Standardize Time Synchronization 8.5 Collect Detailed Audit Logs 8.6 Collect DNS Query Audit Logs 8.7 Collect URL Request Audit Logs 8.8 Collect Command-Line Audit Logs 8.9 Centralize Audit Logs 8.1 Retain Audit Logs 8.11 Conduct Audit Log Reviews ETSI ETSI TR 104 169 V1.1.1 (2025-09) 41 Safeguard Safeguard Name 8.12 Collect Service Provider Logs 9.1 Ensure Use of Only Fully Supported Browsers and Email Clients 9.2 Use DNS Filtering Services 9.3 Maintain and Enforce Network-Based URL Filters 9.4 Restrict Unnecessary or Unauthorized Browser and Email Client Extensions 9.5 Implement DMARC 9.6 Block Unnecessary File Types 9.7 Deploy and Maintain Email Server Anti-Malware Protections 10.1 Deploy and Maintain Anti-Malware Software 10.2 Configure Automatic Anti-Malware Signature Updates 10.3 Disable Autorun and Autoplay for Removable Media 10.4 Configure Automatic Anti-Malware Scanning of Removable Media 10.5 Enable Anti-Exploitation Features 10.6 Centrally Manage Anti-Malware Software 10.7 Use Behaviour-Based Anti-Malware Software 11.2 Perform Automated Backups 12.1 Ensure Network Infrastructure is Up-to-Date 12.3 Securely Manage Network Infrastructure 12.4 Establish and Maintain Architecture Diagram(s) 12.5 Centralize Network Authentication, Authorization, and Auditing (AAA) 12.6 Use of Secure Network Management and Communication Protocols 12.7 Ensure Remote Devices Utilize a VPN and are Connecting to an Enterprise's AAA Infrastructure 12.8 Establish and Maintain Dedicated Computing Resources for All Administrative Work 13.4 Perform Traffic Filtering Between Network Segments 13.5 Manage Access Control for Remote Assets 13.7 Deploy a Host-Based Intrusion Prevention Solution 13.8 Deploy a Network Intrusion Prevention Solution 13.9 Deploy Port-Level Access Control 13.1 Perform Application Layer Filtering 14.2 Train Workforce Members to Recognize Social Engineering Attacks 14.3 Train Workforce Members on Authentication Best Practices 14.4 Train Workforce on Data Handling Best Practices 14.5 Train Workforce Members on Causes of Unintentional Data Exposure 14.6 Train Workforce Members on Recognizing and Reporting Security Incidents 14.7 Train Workforce on How to Identify and Report if Their Enterprise Assets are Missing Security Updates 14.8 Train Workforce on the Dangers of Connecting to and Transmitting Enterprise Data Over Insecure Networks 15.5 Assess Service Providers 16.1 Establish and Maintain a Secure Application Development Process 16.2 Establish and Maintain a Process to Accept and Address Software Vulnerabilities 16.3 Perform Root Cause Analysis on Security Vulnerabilities 16.4 Establish and Manage an Inventory of Third-Party Software Components 16.5 Use Up-to-Date and Trusted Third-Party Software Components 16.6 Establish and Maintain a Severity Rating System and Process for Application Vulnerabilities 16.7 Use Standard Hardening Configuration Templates for Application Infrastructure 16.8 Separate Production and Non-Production Systems 16.9 Train Developers in Application Security Concepts and Secure Coding 16.1 Apply Secure Design Principles in Application Architectures 16.11 Leverage Vetted Modules or Services for Application Security Components 16.12 Implement Code-Level Security Checks 16.13 Conduct Application Penetration Testing 16.14 Conduct Threat Modelling 17.3 Establish and Maintain an Enterprise Process for Reporting Incidents 17.5 Assign Key Roles and Responsibilities 18.1 Establish and Maintain a Penetration Testing Program 18.2 Perform Periodic External Penetration Tests 18.3 Remediate Penetration Test Findings 18.4 Validate Security Measures 18.5 Perform Periodic Internal Penetration Tests ETSI ETSI TR 104 169 V1.1.1 (2025-09) 42 History Document history V1.1.1 September 2025 Publication
e20ec0e4001149cdfbd49276229c67c8	104 168	1 Scope	The present document item provides a mapping between the Critical Security Controls and NIS2 provisions.
e20ec0e4001149cdfbd49276229c67c8	104 168	2 References
e20ec0e4001149cdfbd49276229c67c8	104 168	2.1 Normative references	Normative references are not applicable in the present document.
e20ec0e4001149cdfbd49276229c67c8	104 168	2.2 Informative references	References are either specific (identified by date of publication and/or edition number or version number) or non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the referenced document (including any amendments) applies. NOTE: While any hyperlinks included in this clause were valid at the time of publication ETSI cannot guarantee their long-term validity. The following referenced documents may be useful in implementing an ETSI deliverable or add to the reader's understanding, but are not required for conformance to the present document. [i.1] Directive (EU) 2022/2555 of the European Parliament and of the Council of 14 December 2022 on measures for a high common level of cybersecurity across the Union, amending Regulation (EU) No 910/2014 and Directive (EU) 2018/1972, and repealing Directive (EU) 2016/1148 (NIS 2 Directive). [i.2] Regulation (EU) No. 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC. [i.3] Directive (EU) 2016/1148 of The European Parliament and of The Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union. [i.4] Resolution (EC) 13084/1/20: "Council Resolution on Encryption - Security through encryption and security despite encryption". [i.5] Recommendation 2003/361/EC: "Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises". [i.6] 2020/0365 (COD), COM(2020) 829 Final: "Proposal for a directive of the European Parliament and of the Council on the resilience of critical entities". [i.7] Directive (EU) 2018/1972 of the European Parliament and of the Council of 11 December 2018 establishing the European Electronic Communications Code. [i.8] ETSI TR 103 456: "CYBER; Implementation of the Network and Information Security (NIS) Directive". [i.9] Center for Internet Security: "CIS Controls v8.1, Mapping to NIS2 Directive 2022/2555". [i.10] ETSI TS 103 305-1: "Cyber Security (CYBER); Critical Security Controls for Effective Cyber Defence; Part 1: The Critical Security Controls". [i.11] ETSI TR 103 305-4: "Cyber Security (CYBER); Critical Security Controls for Effective Cyber Defence; Part 4: Facilitation Mechanisms". [i.12] ETSI TR 103 305-5: "Cyber Security (CYBER); Critical Security Controls for Effective Cyber Defence; Part 5: Privacy and personal data protection enhancement". ETSI ETSI TR 104 168 V1.1.1 (2025-09) 6 [i.13] ETSI TR 103 866: "Cyber Security (CYBER); Implementation of the Revised Network and Information Security (NIS2) Directive applying Critical Security Controls". [i.14] ETSI TS 103 992: "Cyber Security (CYBER); Implementation of the Revised Network and Information Security (NIS2) Directive applying Critical Security Controls".
e20ec0e4001149cdfbd49276229c67c8	104 168	3 Definition of terms, symbols and abbreviations
e20ec0e4001149cdfbd49276229c67c8	104 168	3.1 Terms	Void.
e20ec0e4001149cdfbd49276229c67c8	104 168	3.2 Symbols	Void.
e20ec0e4001149cdfbd49276229c67c8	104 168	3.3 Abbreviations	For the purposes of the present document, the following abbreviations apply: COTS Commercial Off The Shelf CSC Critical Security Controls CSF Computer Security Framework DHCP Dynamic Host Configuration Protocol ERM Enterprise Risk Management IG1 Implementation Group 1 IG2 Implementation Group 2 IG3 Implementation Group 3 NIS2 Network and Information Security Directive 2 SSO Single Sign-On 4 Applying the Critical Security Controls for effective implementation of the NIS2 Directive
e20ec0e4001149cdfbd49276229c67c8	104 168	4.1 Methodology and Use	Methodology The methodology used to create the mapping can be useful to anyone attempting to understand the relationships between the Critical Security Controls and NIS2. The overall goal for Control mappings is to be as specific as possible, leaning towards under-mapping versus over-mapping. The general strategy used is to identify all of the aspects within a control and attempt to discern if both items state the same thing. For instance: Control 6.1 - Establish an Access Granting Process Establish and follow a process, preferably automated, for granting access to enterprise assets upon new hire, rights grant, or role change of a user. For a defensive mitigation to map to this CSC Safeguard it is required by NIS2 to have at least one of the following: - A clearly documented process, covering both new employees and changes in access. - All relevant enterprise access control is required by NIS2 to be covered under this process, there can be no separation where different teams control access to different assets. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 7 - Automated tools are ideally used, such as a SSO provider or routing access control through a directory service. - The same process is followed every time a user's rights change, so a user never amasses greater rights access without documentation. If the two concepts are effectively equal, they are mapped with the relationship "equivalent". If they are not equal but still related, the exact type of relationship between two defensive mitigations can be further explored. The relationships can be further analysed to understand how similar or different the two defensive mitigations are. The relationship column will contain one of four possible values: • Equivalent: The defensive mitigation contains the exact same security concept as the Control. • Superset: The Control is partially or mostly related to the defensive mitigation in question, but the Control is broader in concept. • Subset: The Safeguard is partially or mostly related yet is still subsumed within the defensive mitigation. The defensive mitigation in question is broader in concept than the Control. • No relationship: This will be represented by a blank cell. The relationships should be read from left to right, like a sentence. Control Safeguard X is Equivalent to this < >. EXAMPLES: Safeguard 16.8 "Separate Production and Non-Production Systems" is EQUIVALENT to NIST CSF PR.DS-7 "The development and testing environment(s) are separate from the production environment". Safeguard 3.5 "Securely Dispose of Data" is a SUBSET of NIST CSF PR.DS-3 "Assets are formally managed throughout removal, transfers, and disposition". The Critical Security Controls are written with certain principles in mind, such as only having one ask per Safeguard. This means many of the mapping targets are written in a way that contain multiple Safeguards within the same defensive mitigation, so the relationship can often be "Subset". Mappings are available from a variety of sources online, and different individuals may make their own decisions on the type of relationship. Critical Security Controls mappings are intended to be as objective as possible, and improvements are encouraged. Use The clauses in the Critical Security Controls concerning delineation of Asset Types, Security Functions, and Implementation Groups apply to the mappings below. For reference, these delineations are repeated in part here. Asset Types are shown in Figure 4.1-1. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 8 Figure 4.1-1 Security Functions include: • GOVERN - The organization's cybersecurity risk management strategy, expectations, and policy are established, communicated, and monitored. The GOVERN Function provides outcomes to inform what an organization may do to achieve and prioritize the outcomes of the other five Functions in the context of its mission and stakeholder expectations. Governance activities are critical for incorporating cybersecurity into an organization's broader Enterprise Risk Management (ERM) strategy. GOVERN addresses an understanding of organizational context; the establishment of cybersecurity strategy and cybersecurity supply chain risk management; roles, responsibilities, and authorities; policy; and the oversight of cybersecurity strategy. • IDENTIFY - The organization's current cybersecurity risks are understood. Understanding the organization's assets (e.g. data, hardware, software, systems, facilities, services, people), suppliers, and related cybersecurity risks enables an organization to prioritize its efforts consistent with its risk management strategy and the mission needs identified under GOVERN. This Function also includes the identification of improvement opportunities for the organization's policies, plans, processes, procedures, and practices that support cybersecurity risk management to inform efforts under all six Functions. • PROTECT - Safeguards to manage the organization's cybersecurity risks are used. Once assets and risks are identified and prioritized, PROTECT supports the ability to secure those assets to prevent or lower the likelihood and impact of adverse cybersecurity events, as well as to increase the likelihood and impact of taking advantage of opportunities. Outcomes covered by this Function include identity management, authentication, and access control; awareness and training; data security; platform security (i.e. securing the hardware, software, and services of physical and virtual platforms); and the resilience of technology infrastructure. • DETECT - Possible cybersecurity attacks and compromises are found and analysed. DETECT enables the timely discovery and analysis of anomalies, indicators of compromise, and other potentially adverse events that may indicate that cybersecurity attacks and incidents are occurring. This Function supports successful incident response and recovery activities. • RESPOND - Actions regarding a detected cybersecurity incident are taken. RESPOND supports the ability to contain the effects of cybersecurity incidents. Outcomes within this Function cover incident management, analysis, mitigation, reporting, and communication. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 9 • RECOVER - Assets and operations affected by a cybersecurity incident are restored. RECOVER supports the timely restoration of normal operations to reduce the effects of cybersecurity incidents and enable appropriate communication during recovery efforts. Implementation Groups include: • IG1. An IG1 enterprise is small to medium-sized with limited IT and cybersecurity expertise to dedicate toward protecting IT assets and personnel. The principal concern of these enterprises is to keep the business operational, as they have a limited tolerance for downtime. The sensitivity of the data that they are trying to protect is low and principally surrounds employee and financial information. • Safeguards selected for IG1 should be implementable with limited cybersecurity expertise and aimed to thwart general, non-targeted attacks. These Safeguards will also typically be designed to work in conjunction with small or home office Commercial Off-The-Shelf (COTS) hardware and software. • IG2 (Includes IG1). An IG2 enterprise employs individuals responsible for managing and protecting IT infrastructure. These enterprises support multiple departments with differing risk profiles based on job function and mission. Small enterprise units can have regulatory compliance burdens. IG2 enterprises often store and process sensitive client or enterprise information and can withstand short interruptions of service. A major concern is loss of public confidence if a breach occurs. • Safeguards selected for IG2 help security teams cope with increased operational complexity. Some Safeguards will depend on enterprise-grade technology and specialized expertise to properly install and configure. • IG3 (Includes IG1 and IG2). An IG3 enterprise employs security experts that specialize in the different facets of cybersecurity (e.g. risk management, penetration testing, application security). IG3 assets and data contain sensitive information or functions that are subject to regulatory and compliance oversight. An IG3 enterprise should address availability of services and the confidentiality and integrity of sensitive data. Successful attacks can cause significant harm to the public welfare. Safeguards selected for IG3 should abate targeted attacks from a sophisticated adversary and reduce the impact of zero-day attacks.
e20ec0e4001149cdfbd49276229c67c8	104 168	4.2 Applicability Overview	Table 4.2-1: Applicability of the Critical Security Controls to the NIS2 Directive Control Safeguard Title Applicability 1 Inventory and Control of Enterprise Assets 1 of 5 2 Inventory and Control of Software Assets 1 of 7 3 Data Protection 9 of 14 4 Secure Configuration of Enterprise Assets and Software 4 of 12 5 Account Management 4 of 6 6 Access Control Management 8 of 8 7 Continuous Vulnerability Management 7 of 9 8 Audit Log Management 10 of 12 9 Email and Web Browser Protections 2 of 7 10 Malware Defences 3 of 7 11 Data Recovery 4 of 5 12 Network Infrastructure Management 5 of 8 13 Network Monitoring and Defence 2 of 11 14 Security Awareness and Skills Training 3 of 9 15 Service Provider Management 6 of 7 16 Application Software Security 2 of 14 17 Incident Response Management 8 of 9 18 Penetration Testing 1 of 5 ETSI ETSI TR 104 168 V1.1.1 (2025-09) 10
e20ec0e4001149cdfbd49276229c67c8	104 168	4.3 Applying the Critical Security Controls and Safeguards	Table 4.3-1 below provides a mapping by the Critical Security Controls community to the NIS2 provisions to support the indicated requirements [i.9]. Table 4.3-1 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 1 Inventory and Control of Enterprise Assets 1.1 Devices Identify Establish and Maintain Detailed Enterprise Asset Inventory x x x Superset 12.4 Asset inventory 12.4.1 The relevant entities shall develop and maintain a complete, accurate, up-to-date and consistent inventory of their assets. They shall record changes to the entries in the inventory in a traceable manner. 1.1 Devices Identify Establish and Maintain Detailed Enterprise Asset Inventory x x x Superset 12.4 Asset inventory 12.4.2 The granularity of the inventory of the assets shall be at a level appropriate for the needs of the relevant entities. The inventory shall include the following: (a) the list of operations and services and their description, (b) the list of network and information systems and other associated assets supporting the entities' operations and services. 1.1 Devices Identify Establish and Maintain Detailed Enterprise Asset Inventory x x x Superset 12.4 Asset inventory 12.4.3 The relevant entities shall regularly review and update the inventory and their assets and document the history of changes. 1.2 Devices Respond Address Unauthorized Assets x x x 1.3 Devices Detect Utilize an Active Discovery Tool x x 1.4 Devices Identify Use Dynamic Host Configuration Protocol (DHCP) Logging to Update Enterprise Asset Inventory x x 1.5 Devices Detect Use a Passive Asset Discovery Tool x 2 Inventory and Control of Software Assets 2.1 Software Identify Establish and Maintain a Software Inventory x x x ETSI ETSI TR 104 168 V1.1.1 (2025-09) 11 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 2.2 Software Identify Ensure Authorized Software is Currently Supported x x x Subset 6.6 Security patch management 6.6.2 By way of derogation from point 1(a), the relevant entities may choose not to apply security patches when the disadvantages of applying the security patches outweigh the cybersecurity benefits. The relevant entities shall duly document and substantiate the reasons for any such decision. 2.3 Software Respond Address Unauthorized Software x x x 2.4 Software Detect Utilize Automated Software Inventory Tools x x 2.5 Software Protect Allowlist Authorized Software x x 2.6 Software Protect Allowlist Authorized Libraries x x 2.7 Software Protect Allowlist Authorized Scripts x 3 Data Protection 3.1 Data Govern Establish and Maintain a Data Management Process x x x Superset 9.1 Cryptography 9.1.1 For the purpose of Article 21(2), point (h) of Directive (EU) 2022/2555, the relevant entities shall establish, implement and apply a policy and procedures related to cryptography, with a view to ensuring adequate and effective use of cryptography to protect the confidentiality, authenticity and integrity of information in line with the relevant entities' information classification and the results of the risk assessment. 3.1 Data Govern Establish and Maintain a Data Management Process x x x Subset 12.2 Handling of information and assets 12.2.1 The relevant entities shall establish, implement and apply a policy for the proper handling of information and assets in accordance with their network and information security policy, and shall communicate the policy to anyone who uses or handles information and assets. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 12 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 3.1 Data Govern Establish and Maintain a Data Management Process x x x Subset 12.2 Handling of information and assets 12.2.2 The policy shall: (a) cover the entire life cycle of the information and assets, including acquisition, use, storage, transportation and disposal; (b) provide instructions on the safe use, safe storage, safe transport, and the irretrievable deletion and destruction of the information and assets; (c) provide that equipment, hardware, software and data may be transferred to external premises only after approval by bodies authorized by management bodies in accordance with the policies, (d) provide that the transfer shall take place in a secure manner, in accordance with the type of asset or information to be transferred. 3.1 Data Govern Establish and Maintain a Data Management Process x x x Subset 12.2 Handling of information and assets 12.2.3 The relevant entities shall review and, where appropriate, update the policy at planned intervals and when significant incidents or significant changes to operations or risks occur. 3.2 Data Identify Establish and Maintain a Data Inventory x x x 3.3 Data Protect Configure Data Access Control Lists x x x Subset 11.1 Access control policy 11.1.1 For the purpose of Article 21(2), point (i) of Directive (EU) 2022/2555, the relevant entities shall establish, document and implement logical and physical access control policies for the access of persons and processes on network and information systems, based on business requirements as well as network and information system security requirements. 3.4 Data Protect Enforce Data Retention x x x ETSI ETSI TR 104 168 V1.1.1 (2025-09) 13 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 3.5 Data Protect Securely Dispose of Data x x x Subset 12.2 Handling of information and assets 12.2.2 The policy shall: (a) cover the entire life cycle of the information and assets, including acquisition, use, storage, transportation and disposal; (b) provide instructions on the safe use, safe storage, safe transport, and the irretrievable deletion and destruction of the information and assets; (c) provide that equipment, hardware, software and data may be transferred to external premises only after approval by bodies authorized by management bodies in accordance with the policies, (d) provide that the transfer shall take place in a secure manner, in accordance with the type of asset or information to be transferred. 3.6 Data Protect Encrypt Data on End-User Devices x x x Subset 9.1 Cryptography 9.1.1 For the purpose of Article 21(2), point (h) of Directive (EU) 2022/2555, the relevant entities shall establish, implement and apply a policy and procedures related to cryptography, with a view to ensuring adequate and effective use of cryptography to protect the confidentiality, authenticity and integrity of information in line with the relevant entities' information classification and the results of the risk assessment. 3.7 Data Identify Establish and Maintain a Data Classification Scheme x x Subset 12.1 Asset classification 12.1.1 For the purpose of Article 21(2), point (i) of Directive (EU) 2022/2555, the relevant entities shall lay down classification levels of all information and assets in scope of their network and information systems for the level of protection required. 3.7 Data Identify Establish and Maintain a Data Classification Scheme x x Subset 12.1 Asset classification 12.1.2 For the purpose of point 12.1.1, the relevant entities shall: (a) lay down a system of classification levels for information and assets; (b) associate all information and assets with a classification level, based on confidentiality, integrity, authenticity and availability requirements, to indicate the protection required according to their sensitivity, criticality, risk and business value, (c) align the availability requirements of the information and assets with the delivery and recovery objectives set out in their business and disaster recovery plans. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 14 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 3.7 Data Identify Establish and Maintain a Data Classification Scheme x x Subset 12.1 Asset classification 12.1.3 The relevant entities shall conduct periodic reviews of the classification levels of information and assets and update them, where appropriate. 3.8 Data Identify Document Data Flows x x 3.9 Data Protect Encrypt Data on Removable Media x x Subset 12.3 Removable media policy 12.3.1 The relevant entities shall establish, implement and apply a policy on the management of removable storage media and communicate it to their employees and third parties who handle removable storage media at the relevant entities' premises or other locations where the removable media is connected to the relevant entities' network and information systems. 3.9 Data Protect Encrypt Data on Removable Media x x Subset 12.3 Removable media policy 12.3.2 The policy shall: (a) provide for a technical prohibition of the connection of removable media unless there is an organizational reason for their use; (b) provide for disabling self-execution from such media and scanning the media for malicious code before they are used on the entities' systems; (c) provide measures for controlling and protecting portable storage devices containing data while in transit and in storage; (d) where appropriate, provide measures for the use of cryptographic techniques to protect information on removable storage media. 3.10 Data Protect Encrypt Sensitive Data in Transit x x 3.11 Data Protect Encrypt Sensitive Data at Rest x x 3.12 Data Protect Segment Data Processing and Storage Based on Sensitivity x x Subset 11.4 Administration systems 11.4.1 The relevant entities shall restrict and control the use of system administration systems. 3.12 Data Protect Segment Data Processing and Storage Based on Sensitivity x x Subset 11.4 Administration systems 11.4.2 For that purpose, the relevant entities shall: (a) only use system administration systems for system administration purposes, and not for any other operations; (b) separate logically such systems from application software not used for system administrative purposes, (c) protect access to system administration systems through authentication and encryption. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 15 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 3.13 Data Protect Deploy a Data Loss Prevention Solution x 3.14 Data Detect Log Sensitive Data Access x Subset 3.2 Monitoring and logging 3.2.3 The relevant entities shall maintain, document, and review logs. Logs shall include: (a) outbound and inbound network traffic; (b) creation, modification or deletion of users of the relevant entities' network and information systems and extension of the permissions; (c) access to systems and applications; (d) authentication-related events; (e) all privileged access to systems and applications, and activities performed by administrative accounts; (f) access or changes to critical configuration and backup files; (g) event logs and logs from security tools, such as antivirus, intrusion detection systems or firewalls; (h) use of system resources, as well as their performance; (i) physical access to facilities, where appropriate; (j) access to and use of their network equipment and devices; (k) activation, stopping and pausing of the various logs; (l) environmental events, such as flooding alarms, where appropriate. 4 Secure Configuration of Enterprise Assets and Software 4.1 Documentation Govern Establish and Maintain a Secure Configuration Process x x x Subset 6.3 Configuration management 6.3.1 The relevant entities shall establish, document, implement, and monitor configurations, including security configurations of hardware, software, services and networks. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 16 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 4.1 Documentation Govern Establish and Maintain a Secure Configuration Process x x x Subset 6.3 Configuration management 6.3.2 For the purpose of point 6.3.1, the relevant entities shall: (a) lay down configurations, including security configurations, for their hardware, software, services and networks; (b) lay down and implement processes and tools to enforce the laid down configurations, including security configurations, for hardware, software, services and networks, for newly installed systems as well as for operational systems over their lifetime. 4.1 Documentation Govern Establish and Maintain a Secure Configuration Process x x x Subset 6.3 Configuration management 6.3.3 The relevant entities shall review and, where appropriate, update configurations at planned intervals or when significant incidents or significant changes to operations or risks occur 4.2 Documentation Govern Establish and Maintain a Secure Configuration Process for Network Infrastructure x x x Subset 6.3 Configuration management 6.3.1 The relevant entities shall establish, document, implement, and monitor configurations, including security configurations of hardware, software, services and networks. 4.2 Documentation Govern Establish and Maintain a Secure Configuration Process for Network Infrastructure x x x Subset 6.3 Configuration management 6.3.2 For the purpose of point 6.3.1, the relevant entities shall: (a) lay down configurations, including security configurations, for their hardware, software, services and networks; (b) lay down and implement processes and tools to enforce the laid down configurations, including security configurations, for hardware, software, services and networks, for newly installed systems as well as for operational systems over their lifetime. 4.2 Documentation Govern Establish and Maintain a Secure Configuration Process for Network Infrastructure x x x Subset 6.3 Configuration management 6.3.3 The relevant entities shall review and, where appropriate, update configurations at planned intervals or when significant incidents or significant changes to operations or risks occur ETSI ETSI TR 104 168 V1.1.1 (2025-09) 17 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 4.3 Devices Protect Configure Automatic Session Locking on Enterprise Assets x x x Subset 11.6 Authentication 11.6.2 For that purpose, the relevant entities shall: (a) ensure the strength of authentication is appropriate to the classification of the asset to be accessed; (b) control the allocation to users and management of secret authentication information by a process that ensures the confidentiality of the information, including advising personnel on appropriate handling of authentication information; (c) require the change of authentication credentials initially, and when suspicion that the credential is revealed to an unauthorized person; (d) require the reset of authentication credentials and the blocking of users after a predefined number of unsuccessful log-in attempts; (e) terminate inactive sessions after a predefined period of inactivity; and (f) require separate credentials to access privileged access or administrative accounts. 4.4 Devices Protect Implement and Manage a Firewall on Servers x x x 4.5 Devices Protect Implement and Manage a Firewall on End-User Devices x x x 4.6 Devices Protect Securely Manage Enterprise Assets and Software x x x 4.7 Users Protect Manage Default Accounts on Enterprise Assets and Software x x x 4.8 Devices Protect Uninstall or Disable Unnecessary Services on Enterprise Assets and Software x x 4.9 Devices Protect Configure Trusted DNS Servers on Enterprise Assets x x ETSI ETSI TR 104 168 V1.1.1 (2025-09) 18 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 4.10 Devices Protect Enforce Automatic Device Lockout on Portable End- User Devices x x Subset 11.6 Authentication 11.6.2 For that purpose, the relevant entities shall: (a) ensure the strength of authentication is appropriate to the classification of the asset to be accessed; (b) control the allocation to users and management of secret authentication information by a process that ensures the confidentiality of the information, including advising personnel on appropriate handling of authentication information; (c) require the change of authentication credentials initially, and when suspicion that the credential is revealed to an unauthorized person; (d) require the reset of authentication credentials and the blocking of users after a predefined number of unsuccessful log-in attempts; (e) terminate inactive sessions after a predefined period of inactivity; and (f) require separate credentials to access privileged access or administrative accounts. 4.11 Data Protect Enforce Remote Wipe Capability on Portable End-User Devices x x 4.12 Data Protect Separate Enterprise Workspaces on Mobile End-User Devices x 5 Account Management 5.1 Users Identify Establish and Maintain an Inventory of Accounts x x x Subset 11.5 Identification 11.5.1 The relevant entities shall manage the full life cycle of identities of network and information systems and their users. 5.1 Users Identify Establish and Maintain an Inventory of Accounts x x x Subset 11.6 Authentication 11.6.4 The relevant entities shall regularly review the identities and, if no longer needed, deactivate them without delay. 5.2 Users Protect Use Unique Passwords x x x 5.3 Users Protect Disable Dormant Accounts x x x ETSI ETSI TR 104 168 V1.1.1 (2025-09) 19 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 5.4 Users Protect Restrict Administrator Privileges to Dedicated Administrator Accounts x x x Subset 11.3 Privileged accounts and system administration accounts 11.3.2 The policies referred to in point 11.3.1 shall: (a) establish strong identification, authentication such as multi-factor authentication, and authorization procedures for privileged accounts and system administration accounts; (b) set up specific accounts to be used for system administration operations exclusively, such as installation, configuration, management or maintenance; (c) individualize and restrict system administration privileges to the highest extent possible, (d) provide that system administration accounts are only used to connect to system administration systems. 5.4 Users Protect Restrict Administrator Privileges to Dedicated Administrator Accounts x x x Subset 11.6 Authentication 11.6.2 For that purpose, the relevant entities shall: (a) ensure the strength of authentication is appropriate to the classification of the asset to be accessed; (b) control the allocation to users and management of secret authentication information by a process that ensures the confidentiality of the information, including advising personnel on appropriate handling of authentication information; (c) require the change of authentication credentials initially, and when suspicion that the credential is revealed to an unauthorized person; (d) require the reset of authentication credentials and the blocking of users after a predefined number of unsuccessful log-in attempts; (e) terminate inactive sessions after a predefined period of inactivity; and (f) require separate credentials to access privileged access or administrative accounts. 5.5 Users Identify Establish and Maintain an Inventory of Service Accounts x x 5.6 Users Protect Centralize Account Management x x 6 Access Control Management ETSI ETSI TR 104 168 V1.1.1 (2025-09) 20 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 6.1 Documentation Govern Establish an Access Granting Process x x x Subset 11.2 Management of access rights 11.2.1 The relevant entities shall provide, modify, remove and document access rights to network and information systems in accordance with the access control policy referred to in point 11.1. 6.1 Documentation Govern Establish an Access Granting Process x x x Subset 11.2 Management of access rights 11.2.2 The relevant entities shall: (a) assign and revoke access rights based on the principles of need-to-know, least privilege and separation of duties; (b) ensure that access rights are modified accordingly upon termination or change of employment; (c) ensure that access to network and information systems is authorized by their owner; (d) ensure that access rights appropriately address third-party access, such as suppliers and service providers, in particular by limiting access rights in scope and in duration; EN 21 EN (e) maintain a register of access rights granted; (f) apply logging to the management of access rights. 6.2 Documentation Govern Establish an Access Revoking Process x x x Subset 10.3 Termination or change of employment procedures 10.3.2 For the purpose of point 10.3.1, the relevant entities shall: (a) include in the individual's terms and conditions of employment, contract or agreement the responsibilities and duties that are still valid after termination of employment or contract, such as confidentiality clauses; (b) put in place access control policies which ensure that access rights are modified accordingly upon the individual's termination or change of employment; (c) ensure that, after a change of employment, the employee can perform the new tasks. 6.2 Documentation Govern Establish an Access Revoking Process x x x Subset 11.2 Management of access rights 11.2.1 The relevant entities shall provide, modify, remove and document access rights to network and information systems in accordance with the access control policy referred to in point 11.1. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 21 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 6.2 Documentation Govern Establish an Access Revoking Process x x x Subset 11.2 Management of access rights 11.2.2 The relevant entities shall: (a) assign and revoke access rights based on the principles of need-to-know, least privilege and separation of duties; (b) ensure that access rights are modified accordingly upon termination or change of employment; (c) ensure that access to network and information systems is authorized by their owner; (d) ensure that access rights appropriately address third-party access, such as suppliers and service providers, in particular by limiting access rights in scope and in duration; (e) maintain a register of access rights granted; (f) apply logging to the management of access rights. 6.3 Users Protect Require MFA for Externally-Exposed Applications x x x Subset 11.7 Multi-factor authentication 11.7.1 The relevant entities shall ensure that users are authenticated by multiple authentication factors or continuous authentication mechanisms for accessing the entities' network and information systems, where appropriate, in accordance with the classification of the asset to be accessed. 6.3 Users Protect Require MFA for Externally-Exposed Applications x x x Subset 11.7 Multi-factor authentication 11.7.2 The relevant entities shall ensure that the strength of authentication is appropriate for the classification of the asset to be accessed. 6.4 Users Protect Require MFA for Remote Network Access x x x Subset 11.7 Multi-factor authentication 11.7.1 The relevant entities shall ensure that users are authenticated by multiple authentication factors or continuous authentication mechanisms for accessing the entities' network and information systems, where appropriate, in accordance with the classification of the asset to be accessed. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 22 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 6.5 Users Protect Require MFA for Administrative Access x x x Subset 11.3 Privileged accounts and system administration accounts 11.3.2 The policies referred to in point 11.3.1 shall: (a) establish strong identification, authentication such as multi-factor authentication, and authorization procedures for privileged accounts and system administration accounts; (b) set up specific accounts to be used for system administration operations exclusively, such as installation, configuration, management or maintenance; (c) individualize and restrict system administration privileges to the highest extent possible; (d) provide that system administration accounts are only used to connect to system administration systems. 6.5 Users Protect Require MFA for Administrative Access x x x Subset 11.7 Multi-factor authentication 11.7.2 The relevant entities shall ensure that the strength of authentication is appropriate for the classification of the asset to be accessed. 6.6 Software Identify Establish and Maintain an Inventory of Authentication and Authorization Systems x x Subset 11.6 Authentication 11.6.1 The relevant entities shall implement secure authentication procedures and technologies based on access restrictions and the policy on access control. 6.7 Users Protect Centralize Access Control x x Subset 11.6 Authentication 11.6.1 The relevant entities shall implement secure authentication procedures and technologies based on access restrictions and the policy on access control. 6.7 Users Protect Centralize Access Control x x Subset 11.6 Authentication 11.6.3 The relevant entities shall use state-of-the-art authentication methods, in accordance with the associated assessed risk and the classification of the asset to be accessed, and unique authentication information. 6.8 Users Govern Define and Maintain Role-Based Access Control x Superset 1.2 Roles, responsibilities and authorities 1.2.6 Roles, responsibilities and authorities shall be reviewed and, where appropriate, updated by management bodies at planned intervals and when significant incidents or significant changes to operations or risks occur. 6.8 Users Govern Define and Maintain Role-Based Access Control x Subset 11.1 Access control policy 11.1.1 For the purpose of Article 21(2), point (i) of Directive (EU) 2022/2555, the relevant entities shall establish, document and implement logical and physical access control policies for the access of persons and processes on network and information systems, based on business requirements as well as network and information system security requirements. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 23 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 6.8 Users Govern Define and Maintain Role-Based Access Control x Subset 11.2 Management of access rights 11.2.3 The relevant entities shall review access rights at planned intervals and shall modify them based on organizational changes. The relevant entities shall document the results of the review including the necessary changes of access rights. 6.8 Users Govern Define and Maintain Role-Based Access Control x Subset 11.3 Privileged accounts and system administration accounts 11.3.3 The relevant entities shall review access rights of privileged accounts and system administration accounts at planned intervals and be modified based on organizational changes, and shall document the results of the review, including the necessary changes of access rights. 7 Continuous Vulnerability Management 7.1 Documentation Govern Establish and Maintain a Vulnerability Management Process x x x Subset 6.6 Security patch management 6.6.1 The relevant entities shall specify and apply procedures for ensuring that: (a) security patches are applied within a reasonable time after they become available; (b) security patches are tested before being applied in production systems; (c) security patches come from trusted sources and are checked for integrity; (d) additional measures are implemented and residual risks are accepted in cases where a patch is not available or not applied pursuant to point 6.6.2. 7.1 Documentation Govern Establish and Maintain a Vulnerability Management Process x x x Subset 6.10 Vulnerability handling and disclosure 6.10.1 The relevant entities shall obtain information about technical vulnerabilities in their network and information systems, evaluate their exposure to such vulnerabilities, and take appropriate measures to manage the vulnerabilities. 7.1 Documentation Govern Establish and Maintain a Vulnerability Management Process x x x Subset 6.10 Vulnerability handling and disclosure 6.10.4 The relevant entities shall review and, where appropriate, update at planned intervals the channels they use for monitoring vulnerability information. 7.2 Documentation Govern Establish and Maintain a Remediation Process x x x Subset 6.10 Vulnerability handling and disclosure 6.10.3 When justified by the potential impact of the vulnerability, the relevant entities shall create and implement a plan to mitigate the vulnerability. In other cases, the relevant entities shall document and substantiate the reason why the vulnerability does not require remediation. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 24 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 7.3 Software Protect Perform Automated Operating System Patch Management x x x 7.4 Software Protect Perform Automated Application Patch Management x x x 7.5 Software Identify Perform Automated Vulnerability Scans of Internal Enterprise Assets x x Subset 6.10 Vulnerability handling and disclosure 6.10.2 For the purpose of point 6.10.1, the relevant entities shall: (a) monitor information about vulnerabilities through appropriate channels, such as announcements of CSIRTs, competent authorities or information provided by suppliers or service providers. (b) perform, where appropriate, vulnerability scans, and record evidence of the results of the scans, at planned intervals; (c) address, without undue delay, vulnerabilities identified by the relevant entities as critical to their operations; (d) ensure that their vulnerability handling is compatible with their change management and incident management procedures; (e) lay down a procedure for disclosing vulnerabilities in accordance with the applicable national coordinated vulnerability disclosure policy. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 25 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 7.6 Software Identify Perform Automated Vulnerability Scans of Externally-Exposed Enterprise Assets x x Subset 6.10 Vulnerability handling and disclosure 6.10.2 For the purpose of point 6.10.1, the relevant entities shall: (a) monitor information about vulnerabilities through appropriate channels, such as announcements of CSIRTs, competent authorities or information provided by suppliers or service providers; (b) perform, where appropriate, vulnerability scans, and record evidence of the results of the scans, at planned intervals; (c) address, without undue delay, vulnerabilities identified by the relevant entities as critical to their operations; (d) ensure that their vulnerability handling is compatible with their change management and incident management procedures; (e) lay down a procedure for disclosing vulnerabilities in accordance with the applicable national coordinated vulnerability disclosure policy. 7.7 Software Respond Remediate Detected Vulnerabilities x x Superset 6.10 Vulnerability handling and disclosure 6.10.3 When justified by the potential impact of the vulnerability, the relevant entities shall create and implement a plan to mitigate the vulnerability. In other cases, the relevant entities shall document and substantiate the reason why the vulnerability does not require remediation. 8 Audit Log Management 8.1 Documentation Govern Establish and Maintain an Audit Log Management Process x x x Equivalent 3.2 Monitoring and logging 3.2.1 The relevant entities shall lay down procedures and use tools to monitor and log activities on their network and information systems to detect events that could be considered as incidents and respond accordingly to mitigate the impact. 8.1 Documentation Govern Establish and Maintain an Audit Log Management Process x x x Superset 3.2 Monitoring and logging 3.2.2 To the extent feasible, monitoring shall be automated and carried out either continuously or in periodic intervals, subject to business capabilities. The relevant entities shall implement their monitoring activities in a way which minimizes false positives and false negatives. 8.1 Documentation Govern Establish and Maintain an Audit Log Management Process x x x Superset 3.2 Monitoring and logging 3.2.7 The procedures as well as the list of assets that are being logged shall be reviewed and, where appropriate, updated at regular intervals and after significant incidents. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 26 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 8.2 Data Detect Collect Audit Logs x x x Subset 3.2 Monitoring and logging 3.2.1 The relevant entities shall lay down procedures and use tools to monitor and log activities on their network and information systems to detect events that could be considered as incidents and respond accordingly to mitigate the impact. 8.3 Data Protect Ensure Adequate Audit Log Storage x x x 8.4 Network Protect Standardize Time Synchronization x x Equivalent 3.2 Monitoring and logging 3.2.6 The relevant entities shall ensure that all systems have synchronized time sources to be able to correlate logs between systems for event assessment. The relevant entities shall establish and keep a list of all assets that are being logged and ensure that monitoring and logging systems are redundant. The availability of the monitoring and logging systems shall be monitored independently. 8.5 Data Detect Collect Detailed Audit Logs x x Subset 3.2 Monitoring and logging 3.2.3 The relevant entities shall maintain, document, and review logs. Logs shall include: (a) outbound and inbound network traffic; (b) creation, modification or deletion of users of the relevant entities' network and information systems and extension of the permissions; (c) access to systems and applications; (d) authentication-related events; (e) all privileged access to systems and applications, and activities performed by administrative accounts; (f) access or changes to critical configuration and backup files; (g) event logs and logs from security tools, such as antivirus, intrusion detection systems or firewalls; (h) use of system resources, as well as their performance; (i) physical access to facilities, where appropriate; (j) access to and use of their network equipment and devices; (k) activation, stopping and pausing of the various logs; (l) environmental events, such as flooding alarms, where appropriate. 8.6 Data Detect Collect DNS Query Audit Logs x x ETSI ETSI TR 104 168 V1.1.1 (2025-09) 27 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 8.7 Data Detect Collect URL Request Audit Logs x x 8.8 Data Detect Collect Command-Line Audit Logs x x 8.9 Data Detect Centralize Audit Logs x x Subset 3.2 Monitoring and logging 3.2.5 The relevant entities shall maintain and back up logs for a predefined period and shall store the logs at a central location and protect them from unauthorized access or changes. 8.10 Data Protect Retain Audit Logs x x Subset 3.2 Monitoring and logging 3.2.5 The relevant entities shall maintain and back up logs for a predefined period and shall store the logs at a central location and protect them from unauthorized access or changes. 8.11 Data Detect Conduct Audit Log Reviews x x Subset 3.2 Monitoring and logging 3.2.3 The relevant entities shall maintain, document, and review logs. Logs shall include: (a) outbound and inbound network traffic; (b) creation, modification or deletion of users of the relevant entities' network and information systems and extension of the permissions; (c) access to systems and applications; (d) authentication-related events; (e) all privileged access to systems and applications, and activities performed by administrative accounts; (f) access or changes to critical configuration and backup files; (g) event logs and logs from security tools, such as antivirus, intrusion detection systems or firewalls; (h) use of system resources, as well as their performance; (i) physical access to facilities, where appropriate; (j) access to and use of their network equipment and devices; (k) activation, stopping and pausing of the various logs; (l) environmental events, such as flooding alarms, where appropriate. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 28 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 8.11 Data Detect Conduct Audit Log Reviews x x Subset 3.2 Monitoring and logging 3.2.4 The logs shall be reviewed for any unusual or unwanted trends. The relevant entities shall lay down appropriate values for alarm thresholds. If the laid down values for alarm threshold are exceeded, an alarm shall be triggered, where appropriate, automatically. The responsible employee shall ensure that, in case of an alarm, a qualified and appropriate response is initiated. 8.12 Data Detect Collect Service Provider Logs x 9 Email and Web Browser Protections 9.1 Software Protect Ensure Use of Only Fully Supported Browsers and Email Clients x x x 9.2 Devices Protect Use DNS Filtering Services x x x Subset 6.7 Network security 6.7.2 For the purpose of point 6.7.1, the relevant entities shall: (a) document the architecture of the network in a comprehensible and up to date manner; (b) determine and apply controls to protect the relevant entities' internal network domains from unauthorized access; (c) configure controls to prevent accesses not required for the operation of the relevant entities; (d) determine and apply controls for remote access to network and information systems, including access by service providers; (e) not use systems used for administration of the security policy implementation for other purposes; (f) explicitly forbid or deactivate unneeded connections and services; (g) where appropriate, exclusively allow access to the relevant entities' network and information systems by devices authorized by those entities; (h) allow connections of service providers only after an authorization request and for a set time period, such as the duration of a maintenance operation; ETSI ETSI TR 104 168 V1.1.1 (2025-09) 29 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description (i) establish communication between distinct systems only through trusted channels that are isolated using logical, cryptographic or physical separation from other communication channels and provide assured identification of their end points and protection of the channel data from modification or disclosure; (j) adopt an implementation plan for the secure and full transition towards latest generation network layer communication protocols to reduce the attack surface of the networks and establish measures to accelerate such transition; (k) adopt an implementation plan for the deployment of internationally agreed and interoperable modern e-mail communications standards to secure e-mail communications to mitigate vulnerabilities linked to e- mail-related threats and establish measures to accelerate such deployment; (l) apply best practices for Internet routing security and routing hygiene of traffic originating from and destined to the network. 9.3 Network Protect Maintain and Enforce Network-Based URL Filters x x 9.4 Software Protect Restrict Unnecessary or Unauthorized Browser and Email Client Extensions x x 9.5 Network Protect Implement DMARC x x Subset 6.7 Network security 6.7.2 For the purpose of point 6.7.1, the relevant entities shall: (a) document the architecture of the network in a comprehensible and up to date manner; (b) determine and apply controls to protect the relevant entities' internal network domains from unauthorized access; (c) configure controls to prevent accesses not required for the operation of the relevant entities; (d) determine and apply controls for remote access to network and information systems, including access by service providers; ETSI ETSI TR 104 168 V1.1.1 (2025-09) 30 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description (e) not use systems used for administration of the security policy implementation for other purposes; (f) explicitly forbid or deactivate unneeded connections and services; (g) where appropriate, exclusively allow access to the relevant entities' network and information systems by devices authorized by those entities; (h) allow connections of service providers only after an authorization request and for a set time period, such as the duration of a maintenance operation; (i) establish communication between distinct systems only through trusted channels that are isolated using logical, cryptographic or physical separation from other communication channels and provide assured identification of their end points and protection of the channel data from modification or disclosure; (j) adopt an implementation plan for the secure and full transition towards latest generation network layer communication protocols to reduce the attack surface of the networks and establish measures to accelerate such transition; (k) adopt an implementation plan for the deployment of internationally agreed and interoperable modern e-mail communications standards to secure e-mail communications to mitigate vulnerabilities linked to e- mail-related threats and establish measures to accelerate such deployment; (l) apply best practices for Internet routing security and routing hygiene of traffic originating from and destined to the network. 9.6 Network Protect Block Unnecessary File Types x x 9.7 Network Protect Deploy and Maintain Email Server Anti-Malware Protections x ETSI ETSI TR 104 168 V1.1.1 (2025-09) 31 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 10 Malware Defences 10.1 Devices Detect Deploy and Maintain Anti- Malware Software x x x Subset 6.9 Protection against malicious and unauthorized software 6.9.1 The relevant entities shall protect their network and information systems against malicious and unauthorized software. 10.1 Devices Detect Deploy and Maintain Anti- Malware Software x x x Subset 6.9 Protection against malicious and unauthorized software 6.9.2 For that purpose, the relevant entities shall in particular ensure that their network and information systems are equipped with malware detection and repair software, which is updated regularly in accordance with the with the risk assessment and the contractual agreements with the providers. 10.2 Devices Protect Configure Automatic Anti- Malware Signature Updates x x x 10.3 Devices Protect Disable Autorun and Autoplay for Removable Media x x x Subset 12.3 Removable media policy 12.3.1 The relevant entities shall establish, implement and apply a policy on the management of removable storage media and communicate it to their employees and third parties who handle removable storage media at the relevant entities' premises or other locations where the removable media is connected to the relevant entities' network and information systems. 10.3 Devices Protect Disable Autorun and Autoplay for Removable Media x x x Subset 12.3 Removable media policy 12.3.2 The policy shall: (a) provide for a technical prohibition of the connection of removable media unless there is an organizational reason for their use; (b) provide for disabling self-execution from such media and scanning the media for malicious code before they are used on the entities' systems; (c) provide measures for controlling and protecting portable storage devices containing data while in transit and in storage; (d) where appropriate, provide measures for the use of cryptographic techniques to protect information on removable storage media. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 32 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 10.4 Devices Detect Configure Automatic Anti-Malware Scanning of Removable Media x x Subset 12.3 Removable media policy 12.3.1 The relevant entities shall establish, implement and apply a policy on the management of removable storage media and communicate it to their employees and third parties who handle removable storage media at the relevant entities' premises or other locations where the removable media is connected to the relevant entities' network and information systems. 10.5 Devices Protect Enable Anti-Exploitation Features x x 10.6 Devices Protect Centrally Manage Anti-Malware Software x x 10.7 Devices Detect Use Behaviour-Based Anti-Malware Software x x 11 Data Recovery 11.1 Documentation Govern Establish and Maintain a Data Recovery Process x x x Superset 4.2 Backup management 4.2.1 The relevant entities shall maintain backup copies of information and provide sufficient available resources, including facilities, network and information systems and staff. 11.1 Documentation Govern Establish and Maintain a Data Recovery Process x x x Superset 4.2 Backup management 4.2.2 Based on the results of the risk assessment and the business continuity plan, the relevant entities shall lay down backup plans which include the following: (a) recovery times; (b) assurance that backup copies are complete and accurate, including configuration data and information stored in cloud computing service environment; (c) storing backup copies (online or offline) in a safe location or locations, which are not in the same network as the system, and are at sufficient distance to escape any damage from a disaster at the main site; EN 8 EN (d) appropriate physical and logical access controls to backup copies, in accordance with the information classification level; (e) restoring information from backup copies, including approval processes; (f) retention periods based on business and regulatory requirements. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 33 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 11.1 Documentation Govern Establish and Maintain a Data Recovery Process x x x Superset 4.2 Backup management 4.2.4 The relevant entities shall ensure sufficient availability of resources by at least partial redundancy of the following: (a) network and information systems; (b) assets, including facilities, equipment and supplies; (c) personnel with the necessary responsibility, authority and competence; (d) appropriate communication channels. 11.2 Data Recover Perform Automated Backups x x x 11.3 Data Protect Protect Recovery Data x x x Subset 4.2 Backup management 4.2.2 Based on the results of the risk assessment and the business continuity plan, the relevant entities shall lay down backup plans which include the following: (a) recovery times; (b) assurance that backup copies are complete and accurate, including configuration data and information stored in cloud computing service environment; (c) storing backup copies (online or offline) in a safe location or locations, which are not in the same network as the system, and are at sufficient distance to escape any damage from a disaster at the main site; EN 8 EN (d) appropriate physical and logical access controls to backup copies, in accordance with the information classification level; (e) restoring information from backup copies, including approval processes; (f) retention periods based on business and regulatory requirements. 11.3 Data Protect Protect Recovery Data x x x Superset 4.2 Backup management 4.2.3 The relevant entities shall perform regular integrity checks on the backup copies. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 34 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 11.4 Data Recover Establish and Maintain an Isolated Instance of Recovery Data x x x Subset 4.2 Backup management 4.2.2 Based on the results of the risk assessment and the business continuity plan, the relevant entities shall lay down backup plans which include the following: (a) recovery times; (b) assurance that backup copies are complete and accurate, including configuration data and information stored in cloud computing service environment; (c) storing backup copies (online or offline) in a safe location or locations, which are not in the same network as the system, and are at sufficient distance to escape any damage from a disaster at the main site; EN 8 EN (d) appropriate physical and logical access controls to backup copies, in accordance with the information classification level; (e) restoring information from backup copies, including approval processes; (f) retention periods based on business and regulatory requirements. 11.5 Data Recover Test Data Recovery x x Equivalent 4.2 Backup management 4.2.6 The relevant entities shall carry out regular testing of the recovery of backup copies and redundancies to ensure that, in recovery conditions, they can be relied upon and cover the copies, processes and knowledge to perform an effective recovery. The relevant entities shall document the results of the tests and, where needed, take corrective action. 12 Network Infrastructure Management 12.1 Network Protect Ensure Network Infrastructure is Up-to- Date x x x Subset 6.6 Security patch management 6.6.1 The relevant entities shall specify and apply procedures for ensuring that: (a) security patches are applied within a reasonable time after they become available; (b) security patches are tested before being applied in production systems; (c) security patches come from trusted sources and are checked for integrity; (d) additional measures are implemented and residual risks are accepted in cases where a patch is not available or not applied pursuant to point 6.6.2. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 35 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 12.2 Network Protect Establish and Maintain a Secure Network Architecture x x Subset 6.7 Network security 6.7.2 For the purpose of point 6.7.1, the relevant entities shall: (a) document the architecture of the network in a comprehensible and up to date manner; (b) determine and apply controls to protect the relevant entities' internal network domains from unauthorized access; (c) configure controls to prevent accesses not required for the operation of the relevant entities; (d) determine and apply controls for remote access to network and information systems, including access by service providers; (e) not use systems used for administration of the security policy implementation for other purposes; (f) explicitly forbid or deactivate unneeded connections and services; (g) where appropriate, exclusively allow access to the relevant entities' network and information systems by devices authorized by those entities; (h) allow connections of service providers only after an authorization request and for a set time period, such as the duration of a maintenance operation; (i) establish communication between distinct systems only through trusted channels that are isolated using logical, cryptographic or physical separation from other communication channels and provide assured identification of their end points and protection of the channel data from modification or disclosure; (j) adopt an implementation plan for the secure and full transition towards latest generation network layer communication protocols to reduce the attack surface of the networks and establish measures to accelerate such transition; (k) adopt an implementation plan for the deployment of internationally agreed and interoperable modern e-mail communications standards to secure e-mail communications to mitigate vulnerabilities linked to e- mail-related threats and establish measures to accelerate such deployment; ETSI ETSI TR 104 168 V1.1.1 (2025-09) 36 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description (l) apply best practices for Internet routing security and routing hygiene of traffic originating from and destined to the network. 12.2 Network Protect Establish and Maintain a Secure Network Architecture x x Superset 6.8 Network segmentation 6.8.1 The relevant entities shall segment systems into networks or zones in accordance with the results of the risk assessment referred to in point 2.1. They shall segment their systems and networks from third parties' systems and networks. 12.2 Network Protect Establish and Maintain a Secure Network Architecture x x Superset 6.8 Network segmentation 6.8.2 For that purpose, the relevant entities shall: (a) consider the functional, logical and physical relationship, including location, between trustworthy systems and services; (b) apply the same security measures to all network and information systems in the same zone; (c) grant access to a network or zone based on an assessment of its security requirements; (d) keep all systems that are critical to the relevant entities operation or to safety in one or more secured zones; (e) restrict access and communications between and within zones to those necessary for the operation of the relevant entities or for safety; (f) separate the dedicated network for administration of network and information systems from the relevant entities' operational network; (g) segregate network administration channels from other network traffic; (h) separate the production systems for the entities' services from systems used in development and testing, including backups. 12.3 Network Protect Securely Manage Network Infrastructure x x 12.4 Documentation Govern Establish and Maintain Architecture Diagram(s) x x Subset 6.7 Network security 6.7.2 For the purpose of point 6.7.1, the relevant entities shall: (a) document the architecture of the network in a comprehensible and up to date manner; (b) determine and apply controls to protect the relevant entities' internal network domains from unauthorized access; ETSI ETSI TR 104 168 V1.1.1 (2025-09) 37 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description (c) configure controls to prevent accesses not required for the operation of the relevant entities; (d) determine and apply controls for remote access to network and information systems, including access by service providers; (e) not use systems used for administration of the security policy implementation for other purposes; (f) explicitly forbid or deactivate unneeded connections and services; (g) where appropriate, exclusively allow access to the relevant entities' network and information systems by devices authorized by those entities; (h) allow connections of service providers only after an authorization request and for a set time period, such as the duration of a maintenance operation; (i) establish communication between distinct systems only through trusted channels that are isolated using logical, cryptographic or physical separation from other communication channels and provide assured identification of their end points and protection of the channel data from modification or disclosure; (j) adopt an implementation plan for the secure and full transition towards latest generation network layer communication protocols to reduce the attack surface of the networks and establish measures to accelerate such transition; (k) adopt an implementation plan for the deployment of internationally agreed and interoperable modern e-mail communications standards to secure e-mail communications to mitigate vulnerabilities linked to e- mail-related threats and establish measures to accelerate such deployment; (l) apply best practices for Internet routing security and routing hygiene of traffic originating from and destined to the network. 12.4 Documentation Govern Establish and Maintain Architecture Diagram(s) x x Subset 6.7 Network security 6.7.3 The relevant entities shall review and, where appropriate, update these measures at planned intervals and when significant incidents or significant changes to operations or risks occur. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 38 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 12.5 Network Protect Centralize Network Authentication, Authorization, and Auditing (AAA) x x 12.6 Network Protect Use of Secure Network Management and Communication Protocols x x Subset 6.7 Network security 6.7.2 For the purpose of point 6.7.1, the relevant entities shall: (a) document the architecture of the network in a comprehensible and up to date manner; (b) determine and apply controls to protect the relevant entities' internal network domains from unauthorized access; (c) configure controls to prevent accesses not required for the operation of the relevant entities; (d) determine and apply controls for remote access to network and information systems, including access by service providers; EN 14 EN (e) not use systems used for administration of the security policy implementation for other purposes; (f) explicitly forbid or deactivate unneeded connections and services; (g) where appropriate, exclusively allow access to the relevant entities' network and information systems by devices authorized by those entities; (h) allow connections of service providers only after an authorization request and for a set time period, such as the duration of a maintenance operation; (i) establish communication between distinct systems only through trusted channels that are isolated using logical, cryptographic or physical separation from other communication channels and provide assured identification of their end points and protection of the channel data from modification or disclosure; (j) adopt an implementation plan for the secure and full transition towards latest generation network layer communication protocols to reduce the attack surface of the networks and establish measures to accelerate such transition; ETSI ETSI TR 104 168 V1.1.1 (2025-09) 39 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description (k) adopt an implementation plan for the deployment of internationally agreed and interoperable modern e-mail communications standards to secure e-mail communications to mitigate vulnerabilities linked to e- mail-related threats and establish measures to accelerate such deployment; (l) apply best practices for Internet routing security and routing hygiene of traffic originating from and destined to the network. 12.7 Devices Protect Ensure Remote Devices Utilize a VPN and are Connecting to an Enterprise's AAA Infrastructure x x 12.8 Devices Protect Establish and Maintain Dedicated Computing Resources for All Administrative Work x Subset 6.8 Network segmentation 6.8.2 For that purpose, the relevant entities shall: (a) consider the functional, logical and physical relationship, including location, between trustworthy systems and services; (b) apply the same security measures to all network and information systems in the same zone; (c) grant access to a network or zone based on an assessment of its security requirements; (d) keep all systems that are critical to the relevant entities operation or to safety in one or more secured zones; (e) restrict access and communications between and within zones to those necessary for the operation of the relevant entities or for safety; (f) separate the dedicated network for administration of network and information systems from the relevant entities' operational network; (g) segregate network administration channels from other network traffic; EN 15 EN (h) separate the production systems for the entities' services from systems used in development and testing, including backups. 13 Network Monitoring and Defence 13.1 Network Detect Centralize Security Event Alerting x x ETSI ETSI TR 104 168 V1.1.1 (2025-09) 40 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 13.2 Devices Detect Deploy a Host-Based Intrusion Detection Solution x x 13.3 Network Detect Deploy a Network Intrusion Detection Solution x x Subset 6.7 Network security 6.7.1 The relevant entities shall take the appropriate measures to protect their network and information systems from cyber threats. 13.4 Network Protect Perform Traffic Filtering Between Network Segments x x 13.5 Devices Protect Manage Access Control for Remote Assets x x 13.6 Network Detect Collect Network Traffic Flow Logs x x 13.7 Devices Protect Deploy a Host-Based Intrusion Prevention Solution x 13.8 Network Protect Deploy a Network Intrusion Prevention Solution x 13.9 Network Protect Deploy Port-Level Access Control x 13.10 Network Protect Perform Application Layer Filtering x 13.11 Network Detect Tune Security Event Alerting Thresholds x Subset 3.4 Event assessment and classification 3.4.1 The relevant entities shall assess suspicious events to determine whether they constitute incidents and, if so, determine their nature and severity. 14 Security Awareness and Skills Training 14.1 Documentation Govern Establish and Maintain a Security Awareness Program x x x Superset 8.1 Awareness raising and basic cyber hygiene practices 8.1.1 For the purpose of Article 21(2), point (g) of Directive (EU) 2022/2555, the relevant entities shall ensure that their employees are aware of risks, are informed of the importance of cybersecurity and apply cyber hygiene practices. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 41 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 14.1 Documentation Govern Establish and Maintain a Security Awareness Program x x x Subset 8.1 Awareness raising and basic cyber hygiene practices 8.1.2 The relevant entities shall offer to all employees, including members of management bodies, an awareness raising programme, which shall: (a) be scheduled over time, so that the activities are repeated and cover new employees; (b) be established in line with the network and information security policy, topic specific policies and relevant procedures on network and information security; (c) cover cybersecurity risk-management measures in place, contact points and resources for additional information and advice on cybersecurity matters, as well as cyber hygiene practices for users. 14.1 Documentation Govern Establish and Maintain a Security Awareness Program x x x Subset 8.1 Awareness raising and basic cyber hygiene practices 8.1.3 The awareness raising program shall be tested in terms of effectiveness, updated and offered at planned intervals taking into account changes in cyber hygiene practices, and the current threat landscape and risks posed to the relevant entities. 14.1 Documentation Govern Establish and Maintain a Security Awareness Program x x x Superset 8.2 Security training 8.2.5 The program shall be updated and run periodically taking into account applicable policies and rules, assigned roles, responsibilities, as well as known cyber threats and technological developments. 14.2 Users Protect Train Workforce Members to Recognize Social Engineering Attacks x x x 14.3 Users Protect Train Workforce Members on Authentication Best Practices x x x 14.4 Users Protect Train Workforce on Data Handling Best Practices x x x 14.5 Users Protect Train Workforce Members on Causes of Unintentional Data Exposure x x x 14.6 Users Protect Train Workforce Members on Recognizing and Reporting Security Incidents x x x Subset 3.3 Event reporting 3.3.1 The relevant entities shall put in place a simple mechanism allowing their employees, suppliers, and customers to report suspicious events. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 42 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 14.6 Users Protect Train Workforce Members on Recognizing and Reporting Security Incidents x x x Subset 3.3 Event reporting 3.3.2 The relevant entities shall communicate the event reporting mechanism to their suppliers and customers and shall regularly train their employees how to use the mechanism. 14.7 Users Protect Train Workforce on How to Identify and Report if Their Enterprise Assets are Missing Security Updates x x x 14.8 Users Protect Train Workforce on the Dangers of Connecting to and Transmitting Enterprise Data Over Insecure Networks x x x 14.9 Users Protect Conduct Role-Specific Security Awareness and Skills Training x x Superset 8.2 Security training 8.2.1 The relevant entities shall ensure that employees, whose roles require security relevant skill sets and expertise, receive training on network and information system security. 14.9 Users Protect Conduct Role-Specific Security Awareness and Skills Training x x Superset 8.2 Security training 8.2.2 The relevant entities shall establish, implement and apply a training program in line with the network and information security policy, topic-specific policies and other relevant procedures on network and information security which lays down the training needs for certain roles and positions based on criteria. 14.9 Users Protect Conduct Role-Specific Security Awareness and Skills Training x x Superset 8.2 Security training 8.2.3 The training referred to in point 8.2.1 shall be relevant to the job function of the employee and its effectiveness shall be assessed. Training shall take into consideration security measures in place and cover the following: (a) regular and documented instructions regarding the secure configuration and operation of the network and information systems, including mobile devices; (b) regular and documented briefing on known cyber threats; (c) regular and documented training of the behaviour when security-relevant events occur. 14.9 Users Protect Conduct Role-Specific Security Awareness and Skills Training x x Superset 8.2 Security training 8.2.4 The relevant entities shall apply training to staff members who transfer to new positions or roles which require security relevant skill sets and expertise. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 43 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 15 Service Provider Management 15.1 Users Identify Establish and Maintain an Inventory of Service Providers x x x Subset 5.2 Directory of suppliers and service providers 5.2.1 The relevant entities shall maintain and keep up to date a registry of their direct suppliers and service providers, including: (a) contact points for each direct supplier and service provider; (b) a list of ICT products, ICT services, and ICT processes provided by the direct supplier or service provider to the entities. 15.2 Documentation Govern Establish and Maintain a Service Provider Management Policy x x Subset 5.1 Supply chain security policy 5.1.1 For the purpose of Article 21(2), point (d) of Directive (EU) 2022/2555, the relevant entities shall establish, implement and apply a supply chain security policy which governs the relations with their direct suppliers and service providers in order to mitigate the identified risks to the security of network and information systems. In the supply chain security policy, the relevant entities shall identify their role in the supply chain and communicate it to their direct suppliers and service providers. 15.2 Documentation Govern Establish and Maintain a Service Provider Management Policy x x Subset 5.1 Supply chain security policy 5.1.6 The relevant entities shall review the supply chain security policy, and monitor, evaluate and, where necessary, act upon changes in the cybersecurity practices of suppliers and service providers, at planned intervals and when significant changes to operations or risks or significant incidents related to the provision of ICT services or having impact on the security of the ICT product from suppliers and service providers occur. 15.2 Documentation Govern Establish and Maintain a Service Provider Management Policy x x Subset 6.1 Security in acquisition of ICT services or ICT products 6.1.1 For the purpose of Article 21(2), point (e) of Directive (EU) 2022/2555, the relevant entities shall set and implement processes and procedures to manage risks stemming from the acquisition of ICT services or ICT products for components that are critical for the relevant entities' security of network and information systems, based on the risk assessment, from suppliers or service providers throughout their life cycle. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 44 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 15.2 Documentation Govern Establish and Maintain a Service Provider Management Policy x x Subset 6.1 Security in acquisition of ICT services or ICT products 6.1.2 For the purpose of point 6.1.1, the processes and procedures referred to in point 6.1.1 shall include: (a) security requirements to apply to the ICT services or ICT products to be acquired; (b) requirements regarding security updates throughout the entire lifetime of the ICT services or ICT products, or replacement after the end of the support period; (c) information describing the hardware and software components used in the ICT services or ICT products; (d) information describing the implemented cybersecurity functions of the ICT services or ICT products and the configuration required for their secure operation; (e) assurance that the ICT services or ICT products comply with the security requirements according to point (a); (f) appropriate methods for validating that the delivered ICT services or ICT products are compliant to the stated security requirements, as well as documentation of the results of the validation. 15.2 Documentation Govern Establish and Maintain a Service Provider Management Policy x x Superset 6.1 Security in acquisition of ICT services or ICT products 6.1.3 The relevant entities shall review and, where appropriate, update the processes and procedures at planned intervals and when significant incidents occur. 15.3 Users Govern Classify Service Providers x x 15.4 Documentation Govern Ensure Service Provider Contracts Include Security Requirements x x Subset 1.2 Roles, responsibilities and authorities 1.2.2 The relevant entities shall require all personnel and third parties to apply network and information system security in accordance with the established network and information security policy, topic-specific policies and procedures of the relevant entities. 15.4 Documentation Govern Ensure Service Provider Contracts Include Security Requirements x x Subset 3.3 Event reporting 3.3.2 The relevant entities shall communicate the event reporting mechanism to their suppliers and customers and shall regularly train their employees how to use the mechanism. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 45 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 15.4 Documentation Govern Ensure Service Provider Contracts Include Security Requirements x x Subset 5.1 Supply chain security policy 5.1.4 Based on the supply chain security policy and taking into account the results of the risk assessment carried out in accordance with point 2.1 of this Annex, the relevant entities shall ensure that their contracts with the suppliers and service providers specify, where appropriate through service level agreements, specify the following, where appropriate: (a) cybersecurity requirements for the suppliers or service providers, including requirements as regards the security in acquisition of ICT services or ICT products set out in point 6.1; (b) requirements regarding skills and training, and where appropriate certifications, required from the suppliers' or service providers' employees; (c) requirements regarding background checks of the suppliers' and service providers' employees pursuant to point 10.2; (d) an obligation on suppliers and service providers to notify, without undue delay, the relevant entities of incidents that present a risk to the security of the network and information systems of those entities; (e) provisions on repair times; (f) the right to audit or right to receive audit reports; EN 10 EN (g) an obligation on suppliers and service providers to handle vulnerabilities that present a risk to the security of the network and information systems of the relevant entities; (h) requirements regarding subcontracting and, where the relevant entities allow subcontracting, cybersecurity requirements for subcontractors in accordance with the cybersecurity requirements referred to in point (a); (i) obligations on the suppliers and service providers at the termination of the contract, such as retrieval and disposal of the information obtained by the suppliers and service providers in the exercise of their tasks. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 46 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 15.5 Users Govern Assess Service Providers x Subset 5.1 Supply chain security policy 5.1.2 As part of the supply chain security policy referred to in point 5.1.1, the relevant entities shall lay down criteria to select and contract suppliers and service providers. Those criteria shall include the following: (a) the cybersecurity practices of the suppliers and service providers, including their secure development procedures; (b) the ability of the suppliers and service providers to meet cybersecurity specifications set by the entities; (c) the overall quality and resilience of ICT products and ICT services and the cybersecurity risk- management measures embedded in them, including the risks and classification level of the ICT products and ICT services; (d) the ability of the relevant entities to diversify sources of supply and limit vendor lock-in. 15.5 Users Govern Assess Service Providers x Subset 5.1 Supply chain security policy 5.1.5 The relevant entities shall take into account the elements referred to in points 5.1.2 and 5.1.3 as part of the selection process of new suppliers and service providers, as well as part of the procurement process referred to in point 6.1. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 47 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 15.6 Data Govern Monitor Service Providers x Subset 5.1 Supply chain security policy 5.1.4 Based on the supply chain security policy and taking into account the results of the risk assessment carried out in accordance with point 2.1 of this Annex, the relevant entities shall ensure that their contracts with the suppliers and service providers specify, where appropriate through service level agreements, specify the following, where appropriate: (a) cybersecurity requirements for the suppliers or service providers, including requirements as regards the security in acquisition of ICT services or ICT products set out in point 6.1; (b) requirements regarding skills and training, and where appropriate certifications, required from the suppliers' or service providers' employees; (c) requirements regarding background checks of the suppliers' and service providers' employees pursuant to point 10.2; (d) an obligation on suppliers and service providers to notify, without undue delay, the relevant entities of incidents that present a risk to the security of the network and information systems of those entities; (e) provisions on repair times; (f) the right to audit or right to receive audit reports; EN 10 EN (g) an obligation on suppliers and service providers to handle vulnerabilities that present a risk to the security of the network and information systems of the relevant entities; (h) requirements regarding subcontracting and, where the relevant entities allow subcontracting, cybersecurity requirements for subcontractors in accordance with the cybersecurity requirements referred to in point (a); (i) obligations on the suppliers and service providers at the termination of the contract, such as retrieval and disposal of the information obtained by the suppliers and service providers in the exercise of their tasks. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 48 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 15.6 Data Govern Monitor Service Providers x Subset 5.1 Supply chain security policy 5.1.6 The relevant entities shall review the supply chain security policy, and monitor, evaluate and, where necessary, act upon changes in the cybersecurity practices of suppliers and service providers, at planned intervals and when significant changes to operations or risks or significant incidents related to the provision of ICT services or having impact on the security of the ICT product from suppliers and service providers occur. 15.6 Data Govern Monitor Service Providers x Subset 5.1 Supply chain security policy 5.1.7 For the purpose of point 5.1.5, the relevant entities shall: (a) regularly monitor reports on the implementation of the service level agreements, where applicable; (b) review incidents related to ICT products and ICT services from suppliers and service providers; (c) assess the need for unscheduled reviews and document the findings in a comprehensible manner; (d) analyse the risks presented by changes related to ICT products and ICT services from suppliers and service providers and, where appropriate, take mitigating measures in a timely manner. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 49 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 15.7 Data Protect Securely Decommission Service Providers x Subset 5.1 Supply chain security policy 5.1.4 Based on the supply chain security policy and taking into account the results of the risk assessment carried out in accordance with point 2.1. of this Annex, the relevant entities shall ensure that their contracts with the suppliers and service providers specify, where appropriate through service level agreements, specify the following, where appropriate: (a) cybersecurity requirements for the suppliers or service providers, including requirements as regards the security in acquisition of ICT services or ICT products set out in point 6.1; (b) requirements regarding skills and training, and where appropriate certifications, required from the suppliers' or service providers' employees; (c) requirements regarding background checks of the suppliers' and service providers' employees pursuant to point 10.2; (d) an obligation on suppliers and service providers to notify, without undue delay, the relevant entities of incidents that present a risk to the security of the network and information systems of those entities; (e) provisions on repair times; (f) the right to audit or right to receive audit reports; EN 10 EN (g) an obligation on suppliers and service providers to handle vulnerabilities that present a risk to the security of the network and information systems of the relevant entities; (h) requirements regarding subcontracting and, where the relevant entities allow subcontracting, cybersecurity requirements for subcontractors in accordance with the cybersecurity requirements referred to in point (a); (i) obligations on the suppliers and service providers at the termination of the contract, such as retrieval and disposal of the information obtained by the suppliers and service providers in the exercise of their tasks. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 50 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 16 Application Software Security 16.1 Documentation Govern Establish and Maintain a Secure Application Development Process x x Subset 6.2 Secure development life cycle 6.2.1 The relevant entities shall lay down, implement and apply rules for the secure development of network and information systems, including software, and apply them when acquiring or developing network and information systems. The rules shall cover all development phases, including specification, design, development, implementation and testing. 16.1 Documentation Govern Establish and Maintain a Secure Application Development Process x x Subset 6.2 Secure development life cycle 6.2.2 The relevant entities shall: (a) carry out an analysis of security requirements at the specification and design phases of any development or acquisition project undertaken by the relevant entities or on behalf of those entities; (b) apply principles for engineering secure systems and secure coding principles to any information system development activities such as promoting cybersecurity-by-design, zero trust architectures; (c) lay down security requirements regarding development environments; (d) establish and implement security testing processes in the development life cycle; (e) appropriately select, protect and manage security test information; EN 12 EN (f) sanitise and anonymize testing data according to the risk assessment. 16.1 Documentation Govern Establish and Maintain a Secure Application Development Process x x Subset 6.2 Secure development life cycle 6.2.3 For outsourced development and procurement of network and information systems, the relevant entities shall apply the policies and procedures referred to in points 5 and 6.1. 16.1 Documentation Govern Establish and Maintain a Secure Application Development Process x x Subset 6.2 Secure development life cycle 6.2.4 The relevant entities shall review and, where appropriate, update their secure development rules at planned intervals. 16.2 Documentation Govern Establish and Maintain a Process to Accept and Address Software Vulnerabilities x x 16.3 Software Protect Perform Root Cause Analysis on Security Vulnerabilities x x ETSI ETSI TR 104 168 V1.1.1 (2025-09) 51 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 16.4 Software Identify Establish and Manage an Inventory of Third-Party Software Components x x 16.5 Software Protect Use Up-to-Date and Trusted Third-Party Software Components x x 16.6 Documentation Govern Establish and Maintain a Severity Rating System and Process for Application Vulnerabilities x x 16.7 Software Protect Use Standard Hardening Configuration Templates for Application Infrastructure x x 16.8 Network Protect Separate Production and Non-Production Systems x x 16.9 Users Protect Train Developers in Application Security Concepts and Secure Coding x x 16.10 Software Protect Apply Secure Design Principles in Application Architectures x x Subset 6.2 Secure development life cycle 6.2.2 The relevant entities shall: (a) carry out an analysis of security requirements at the specification and design phases of any development or acquisition project undertaken by the relevant entities or on behalf of those entities; (b) apply principles for engineering secure systems and secure coding principles to any information system development activities such as promoting cybersecurity-by-design, zero trust architectures; (c) lay down security requirements regarding development environments; (d) establish and implement security testing processes in the development life cycle; (e) appropriately select, protect and manage security test information; (f) sanitise and anonymize testing data according to the risk assessment. 16.11 Software Protect Leverage Vetted Modules or Services for Application Security Components x x ETSI ETSI TR 104 168 V1.1.1 (2025-09) 52 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 16.12 Software Protect Implement Code-Level Security Checks x 16.13 Software Detect Conduct Application Penetration Testing x 16.14 Software Protect Conduct Threat Modelling x 17 Incident Response Management 17.1 Users Respond Designate Personnel to Manage Incident Handling x x x 17.2 Documentation Govern Establish and Maintain Contact Information for Reporting Security Incidents x x x Subset 3.5 Incident response 3.5.3 The relevant entities shall establish communication plans and procedures: (a) with the Computer Security Incident Response Teams (CSIRTs) or, where applicable, the competent authorities, related to incident notification; (b) with relevant internal and external stakeholders. 17.3 Documentation Govern Establish and Maintain an Enterprise Process for Reporting Incidents x x x Subset 3.3 Event reporting 3.3.1 The relevant entities shall put in place a simple mechanism allowing their employees, suppliers, and customers to report suspicious events. 17.3 Documentation Govern Establish and Maintain an Enterprise Process for Reporting Incidents x x x Subset 3.5 Incident response 3.5.3 The relevant entities shall establish communication plans and procedures: (a) with the Computer Security Incident Response Teams (CSIRTs) or, where applicable, the competent authorities, related to incident notification; (b) with relevant internal and external stakeholders. 17.4 Documentation Govern Establish and Maintain an Incident Response Process x x Subset 3.5 Incident response 3.5.1 The relevant entities shall respond to incidents in accordance with documented procedures and in a timely manner. 17.4 Documentation Govern Establish and Maintain an Incident Response Process x x Subset 3.5 Incident response 3.5.2 The incident response procedures shall include the following stages: (a) incident containment, to prevent the consequences of the incident from spreading; (b) eradication, to prevent the incident from continuing or reappearing, (c) recovery from the incident, where necessary. 17.4 Documentation Govern Establish and Maintain an Incident Response Process x x Subset 3.5 Incident response 3.5.4 The relevant entities shall log incident response activities, and record evidence. 17.5 Users Respond Assign Key Roles and Responsibilities x x ETSI ETSI TR 104 168 V1.1.1 (2025-09) 53 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 17.6 Users Respond Define Mechanisms for Communicating During Incident Response x x Subset 3.5 Incident response 3.5.3 The relevant entities shall establish communication plans and procedures: (a) with the Computer Security Incident Response Teams (CSIRTs) or, where applicable, the competent authorities, related to incident notification; (b) with relevant internal and external stakeholders. 17.7 Users Recover Conduct Routine Incident Response Exercises x x Equivalent 3.5 Incident response 3.5.5 The relevant entities shall test at planned intervals their incident response procedures. 17.8 Users Recover Conduct Post-Incident Reviews x x Equivalent 3.6 Post-incident reviews 3.6.1 The relevant entities shall carry out post-incident reviews that shall identify the root cause of the incident and result in lessons learned to reduce the occurrence and consequences of future incidents. 17.8 Users Recover Conduct Post-Incident Reviews x x Superset 3.6 Post-incident reviews 3.6.2 The relevant entities shall ensure that post-incident reviews contribute to improving their approach to network and information security, to risk treatment measures, and to incident handling, detection and response procedures. 17.8 Users Recover Conduct Post-Incident Reviews x x Superset 3.6 Post-incident reviews 3.6.3 The relevant entities shall review at planned intervals if significant incidents led to post-incident reviews. 17.9 Documentation Recover Establish and Maintain Security Incident Thresholds x Subset 3.4 Event assessment and classifica- tion 3.4.1 The relevant entities shall assess suspicious events to determine whether they constitute incidents and, if so, determine their nature and severity. 17.9 Documentation Recover Establish and Maintain Security Incident Thresholds x Subset 3.4 Event assessment and classification 3.4.2 For the purpose of point 3.4.1, the relevant entities shall act in the following manner: (a) carry out the assessment based on predefined criteria laid down in advance, and on a triage to determine prioritization of incident containment and eradication; (b) assess the existence of recurring incidents as referred to in Article 4 of this Regulation on a quarterly basis; (c) review the appropriate logs for the purposes of event assessment and classification; (d) put in place a process for log correlation and analysis, and (e) reassess and reclassify events in case of new information becoming available or after analysis of previously available information. ETSI ETSI TR 104 168 V1.1.1 (2025-09) 54 Control Safeguard Control Asset Type Safeguard Security Function Control / Safeguard Title IG1 IG2 IG3 NIS2 Relationship NIS 2 Provision NIS 2 Requirement Category NIS2 Requirement # NIS 2 Requirement Description 18 Penetration Testing 18.1 Documentation Govern Establish and Maintain a Penetration Testing Program x x Subset 6.5 Security testing 6.5.1 The relevant entities shall establish, implement and apply a policy and procedures for security testing. 18.1 Documentation Govern Establish and Maintain a Penetration Testing Program x x Subset 6.5 Security testing 6.5.2 The relevant entities shall: (a) establish, based on the risk assessment, the need, scope, frequency and type of security tests; (b) carry out security tests according to a documented test methodology, covering the components identified as relevant for secure operation in a risk analysis; (c) document the type, scope, time and results of the tests, including assessment of criticality and mitigating actions for each finding; (d) apply mitigating actions in case of critical findings. 18.2 Network Detect Perform Periodic External Penetration Tests x x 18.3 Network Protect Remediate Penetration Test Findings x x 18.4 Network Protect Validate Security Measures x 18.5 Network Detect Perform Periodic Internal Penetration Tests x ETSI ETSI TR 104 168 V1.1.1 (2025-09) 55 Annex A: Unmapped NIS2 Provisions The following NIS2 Directive provisions NOT mapped to the Critical Security Controls Safeguards. Table A.1 Directive Requirement# Directive Provision 1.1.1 Policy on the security of network and information systems 1.1.2 Policy on the security of network and information systems 1.2.1 Roles, responsibilities and authorities 1.2.3 Roles, responsibilities and authorities 1.2.4 Roles, responsibilities and authorities 1.2.5 Roles, responsibilities and authorities 2.1.1 Risk management framework 2.1.2 Risk management framework 2.1.3 Risk management framework 2.2.1 Compliance monitoring 2.2.2 Compliance monitoring 2.2.3 Compliance monitoring 2.3.1 Independent review of information and network security 2.3.2 Independent review of information and network security 2.3.3 Independent review of information and network security 2.3.4 Independent review of information and network security 3.1.1 Incident handling policy 3.1.2 Incident handling policy 3.1.3 Incident handling policy 4.1.1 Business continuity and disaster recovery plans 4.1.2 Business continuity and disaster recovery plans 4.1.3 Business continuity and disaster recovery plans 4.1.4 Business continuity and disaster recovery plans 4.2.5 Backup management 4.3.1 Crisis management 4.3.2 Crisis management 4.3.3 Crisis management 4.3.4 Crisis management 5.1.3 Supply chain security policy 6.4.1 Change management, repairs and maintenance 6.4.2 Change management, repairs and maintenance 6.4.3 Change management, repairs and maintenance 6.4.4 Change management, repairs and maintenance 6.5.3 Security testing 6.8.3 Network segmentation 7.1.1 Policies and procedures 7.1.2 Policies and procedures 7.1.3 Policies and procedures 9.1.2 Cryptography 9.1.3 Cryptography 10.1.1 Human resources security 10.1.2 Human resources security 10.1.3 Human resources security 10.2.1 Background checks 10.2.2 Background checks 10.2.3 Background checks 10.3.1 Termination or change of employment procedures 10.4.1 Termination or change of employment procedures 10.4.2 Termination or change of employment procedures 11.1.2 Access control policy 11.1.3 Access control policy 11.3.1 Privileged accounts and system administration accounts 11.5.2 Identification ETSI ETSI TR 104 168 V1.1.1 (2025-09) 56 Directive Requirement# Directive Provision 11.5.3 Identification 12.3.3 Removable media policy 12.5.1 Return or deletion of assets upon termination of employment 13.1.1 Supporting utilities 13.1.2 Supporting utilities 13.1.3 Supporting utilities 13.2.1 Protection against physical and environmental threats 13.2.2 Protection against physical and environmental threats 13.2.3 Protection against physical and environmental threats 13.3.1 Perimeter and physical access control 13.3.2 Perimeter and physical access control 13.3.3 Perimeter and physical access control ETSI ETSI TR 104 168 V1.1.1 (2025-09) 57 Annex B: Unmapped Critical Security Control Safeguards The following Critical Security Controls Safeguards are NOT mapped to the NIS2 Directive provisions Table B.1 Safeguard Safeguard Name 1.2 Address Unauthorized Assets 1.3 Utilize an Active Discovery Tool 1.4 Use Dynamic Host Configuration Protocol (DHCP) Logging to Update Enterprise Asset Inventory 1.5 Use a Passive Asset Discovery Tool 2.1 Establish and Maintain a Software Inventory 2.3 Address Unauthorized Software 2.4 Utilize Automated Software Inventory Tools 2.5 Allowlist Authorized Software 2.6 Allowlist Authorized Libraries 2.7 Allowlist Authorized Scripts 3.2 Establish and Maintain a Data Inventory 3.4 Enforce Data Retention 3.8 Document Data Flows 3.1 Encrypt Sensitive Data in Transit 3.1 Encrypt Sensitive Data at Rest 3.1 Deploy a Data Loss Prevention Solution 4.4 Implement and Manage a Firewall on Servers 4.5 Implement and Manage a Firewall on End-User Devices 4.6 Securely Manage Enterprise Assets and Software 4.7 Manage Default Accounts on Enterprise Assets and Software 4.8 Uninstall or Disable Unnecessary Services on Enterprise Assets and Software 4.9 Configure Trusted DNS Servers on Enterprise Assets 4.1 Enforce Remote Wipe Capability on Portable End-User Devices 4.1 Separate Enterprise Workspaces on Mobile End-User Devices 5.2 Use Unique Passwords 5.3 Disable Dormant Accounts 5.5 Establish and Maintain an Inventory of Service Accounts 5.6 Centralize Account Management 7.3 Perform Automated Operating System Patch Management 7.4 Perform Automated Application Patch Management 8.3 Ensure Adequate Audit Log Storage 8.6 Collect DNS Query Audit Logs 8.7 Collect URL Request Audit Logs 8.8 Collect Command-Line Audit Logs 8.1 Collect Service Provider Logs 9.1 Ensure Use of Only Fully Supported Browsers and Email Clients 9.3 Maintain and Enforce Network-Based URL Filters 9.4 Restrict Unnecessary or Unauthorized Browser and Email Client Extensions 9.6 Block Unnecessary File Types 9.7 Deploy and Maintain Email Server Anti-Malware Protections 10 Configure Automatic Anti-Malware Signature Updates 11 Enable Anti-Exploitation Features 11 Centrally Manage Anti-Malware Software 11 Use Behaviour-Based Anti-Malware Software 11 Perform Automated Backups 12 Securely Manage Network Infrastructure 13 Centralize Network Authentication, Authorization, and Auditing (AAA) 13 Ensure Remote Devices Utilize a VPN and are Connecting to an Enterprise's AAA Infrastructure 13 Centralize Security Event Alerting 13 Deploy a Host-Based Intrusion Detection Solution 13 Perform Traffic Filtering Between Network Segments 14 Manage Access Control for Remote Assets 14 Collect Network Traffic Flow Logs 14 Deploy a Host-Based Intrusion Prevention Solution 14 Deploy a Network Intrusion Prevention Solution ETSI ETSI TR 104 168 V1.1.1 (2025-09) 58 Safeguard Safeguard Name 14 Deploy Port-Level Access Control 13 Perform Application Layer Filtering 14 Train Workforce Members to Recognize Social Engineering Attacks 14 Train Workforce Members on Authentication Best Practices 14 Train Workforce on Data Handling Best Practices 15 Train Workforce Members on Causes of Unintentional Data Exposure 15 Train Workforce on How to Identify and Report if Their Enterprise Assets are Missing Security Updates 15 Train Workforce on the Dangers of Connecting to and Transmitting Enterprise Data Over Insecure Networks 15 Classify Service Providers 16 Establish and Maintain a Process to Accept and Address Software Vulnerabilities 16 Perform Root Cause Analysis on Security Vulnerabilities 16 Establish and Manage an Inventory of Third-Party Software Components 17 Use Up-to-Date and Trusted Third-Party Software Components 17 Establish and Maintain a Severity Rating System and Process for Application Vulnerabilities 17 Use Standard Hardening Configuration Templates for Application Infrastructure 17 Separate Production and Non-Production Systems 17 Train Developers in Application Security Concepts and Secure Coding 16 Leverage Vetted Modules or Services for Application Security Components 16 Implement Code-Level Security Checks 16 Conduct Application Penetration Testing 16 Conduct Threat Modelling 17 Designate Personnel to Manage Incident Handling 18 Assign Key Roles and Responsibilities 18 Perform Periodic External Penetration Tests 18 Remediate Penetration Test Findings 18 Validate Security Measures 19 Perform Periodic Internal Penetration Tests ETSI ETSI TR 104 168 V1.1.1 (2025-09) 59 History Document history V1.1.1 September 2025 Publication
2ba1876e0259e748d226a329803049d9	104 160	1 Scope	The present document will focus on presenting the results, observations and lessons learnt from the ERATOSTHENES and CERTIFY projects that tackle the complex security challenges of the Internet of Things (IoT) with a focus on managing the entire lifecycle of these networks, with a specific focus on distributed trust management and digital identity solutions, and the certification process.
2ba1876e0259e748d226a329803049d9	104 160	2 References
2ba1876e0259e748d226a329803049d9	104 160	2.1 Normative references	Normative references are not applicable in the present document.
2ba1876e0259e748d226a329803049d9	104 160	2.2 Informative references	References are either specific (identified by date of publication and/or edition number or version number) or non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the referenced document (including any amendments) applies. NOTE: While any hyperlinks included in this clause were valid at the time of publication ETSI cannot guarantee their long-term validity. The following referenced documents may be useful in implementing an ETSI deliverable or add to the reader's understanding, but are not required for conformance to the present document. [i.1] Directive (EU) 2022/2555 of the European Parliament and of the Council of 14 December 2022 on measures for a high common level of cybersecurity across the Union, amending Regulation (EU) No 910/2014 and Directive (EU) 2018/1972, and repealing Directive (EU) 2016/1148 (NIS 2 Directive). [i.2] Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). [i.3] Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act). [i.4] ETSI TS 103 097 (V2.1.1): "Intelligent Transport Systems (ITS); Security; Security header and certificate formats; Release 2". [i.5] Common Criteria for Information Technology Security Evaluation. [i.6] IETF RFC 9019 (2021): "A Firmware Update Architecture for Internet of Things". [i.7] IETF RFC 8520 (2019): "Manufacturer Usage Description Specification", E. Lear, D. Romascanu, and R. Droms. [i.8] IETF RFC 7950 (2016): "The YANG 1.1 Data Modeling Language", M. Bjorklund. [i.9] IETF RFC 8259 (2017): "The JavaScript Object Notation (JSON) Data Interchange Format", T. Bray. [i.10] "CVE vulnerabilities by date", May 2022, [Online]. [i.11] NIST SP 1800-15: "Securing Small-Business and Home Internet of Things Devices", Gaithersburg, MD, USA, 2019. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 7 [i.12] S. N. Matheu-García and A. Skarmeta: "Defining the Threat Manufacturer Usage Description Model for Sharing Mitigation Actions", 2022 1st International Conference on 6G Networking (6GNet), Paris, France, 2022, pp. 1-4, doi: 10.1109/6GNet54646.2022.9830415. [i.13] S. N. M. García, A. M. Zarca, J. L. Hernández-Ramos, J. B. Bernabé, and A. S. Gómez: "Enforcing behavioral profiles through software-defined networks in the industrial Internet of Things", Appl. Sci., vol. 9, no. 21, p. 4576, October 2019. [i.14] Elliot, Mark & Domingo-Ferrer, Josep (2018): "The future of statistical disclosure control". [i.15] UN Regulation No. 155: "Uniform provisions concerning the approval of vehicles with regards to cyber security and cyber security management system". [i.16] UN Regulation No. 156: "Uniform provisions concerning the approval of vehicles with regards to software update and software updates management system". [i.17] AC 20-168: "Certification Guidance for Installation of Non-Essential, Non-Required Aircraft Cabin Systems & Equipment (CS&E)", 2010, Federal Aviation Administration. [i.18] RTCA DO-313: "Certification Guidance for Installation of Non-Essential, Non-Required Aircraft Cabin Systems and Equipment", 2008, Radio Technical Commission for Aeronautics. [i.19] ETSI EN 303 645 (V3.1.3): "CYBER; Cyber Security for Consumer Internet of Things: Baseline Requirements". [i.20] Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity requirements for products with digital elements and amending Regulations (EU) No 168/2013 and (EU) 2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act). [i.21] ENISA: "EUCS - Cloud Services Scheme EUCS, a candidate cybersecurity certification scheme for cloud services", 2020. [i.22] Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (Radio Equipment Directive (RED)). [i.23] ENISA: "Good practices for security of IOT; Secure Software Development Lifecycle", 2019. [i.24] "Product Security and Telecommunications Infrastructure (PSTI) Act", 2024, United Kingdom. [i.25] IETF RFC 3748 (2004): "Extensible Authentication Protocol (EAP)", B. Aboba, L. Blunk, J. Vollbrecht, J. Carlson and H. Levkowetz. [i.26] NIST: "NISTIR 8259 Series". [i.27] IETF: "A summary of security-enabling technologies for IoT devices", 2024. [i.28] Global Platform: "Security Evaluation Standard for IoT Platforms (SESIP)". [i.29] ETSI TS 103 645 (V3.1.1): "CYBER; Cyber Security for Consumer Internet of Things: Baseline Requirements". [i.30] ETSI TS 103 701 (V2.1.1) (2025-05): "Cyber Security (CYBER); Cyber Security for Consumer Internet of Things: Conformance Assessment of Baseline Requirements". [i.31] IoT Security Foundation: "IoTSF Security Assurance Framework", Release 3.0, 2021. [i.32] H. Kaur, and K. Kaur: "Secure elements for IoT devices: A survey", vol. 176, no. 102918, 2021. [i.33] S. P. and N. Santos: "Demystifying Arm TrustZone: A Comprehensive Survey", ACM Comput Surv., vol. 51, no. 6, pp. 1-36, 2019. [i.34] S. N. Matheu, J. L. Hernández-Ramos, A. F. Skarmeta, and G. Baldini: "A Survey of Cybersecurity Certification for the Internet of Things", ACM Comput. Surv. CSUR, vol. 53, no. 6, pp. 1-36, 2. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 8 [i.35] S. N. Matheu, A. Robles Enciso, A. Molina Zarca, D. Garcia-Carrillo, J. L. Hernández-Ramos, J. Bernal Bernabe, and A. Skarmeta: "Security Architecture for Defining and Enforcing Security Profiles in DLT/SDN-Based IoT Systems", Sensors, vol. 20, no. 7, p. 1882, January 2020. [i.36] S. N. Matheu, J. L. Hernandez-Ramos, S. Perez, and A. F. Skarmeta: "Extending MUD profiles through an Automated IoT Security Testing Methodology", IEEE Access, pp. 1-20, 2019. [i.37] H. Cavusoglu, H. Cavusoglu, and S. Raghunathan: "Efficiency of Vulnerability Disclosure Mechanisms to Disseminate Vulnerability Knowledge", IEEE Trans. Softw. Eng., vol. 33, no. 3, pp. 171-185, March 2007. [i.38] S. E. Jaouhari and E. Bouvet: "Secure firmware Over-The-Air updates for IoT: Survey, challenges, and discussions, Internet of Things", Internet Things, vol. 18, 2022. [i.39] "ENISA Baseline Security Recommendations for IoT \| OWASP IoT Top 10 2018 Mapping Project". [i.40] TÜV SÜD: "ETSI EN 303 645 Cybersecurity for Consumer Internet Of Things: What It Is and Why It"s Important". [i.41] EUROCAE. [i.42] Federal Aviation Administration (FAA). [i.43] European Union Aviation Safety Agency (EASA). [i.44] Australian Government- Australian Cyber Security Centre: "IoT Code of Practice - Guidance for Manufacturers". [i.45] ENISA: "Cyber Resilience Act Requirements Standards Mapping - Joint Research Centre & ENISA Joint Analysis", 2024. [i.46] CISA: "Shifting the Balance of Cybersecurity Risk: Principles and Approaches for Security-by- Design and -Default", 2023. [i.47] CISA: "Shifting the Balance of Cybersecurity Risk: Principles and Approaches for Secure by Design Software", 2023. [i.48] Commission Implementing Regulation (EU) 2024/482 of 31 January 2024 laying down rules for the application of Regulation (EU) 2019/881 of the European Parliament and of the Council as regards the adoption of the European Common Criteria-based cybersecurity certification scheme (EUCC). [i.49] ISO/IEC 15408-1:2022: " Information security, cybersecurity and privacy protection — Evaluation criteria for IT security — Part 1: Introduction and general model". [i.50] J. L. Hernández-Ramos et al.: "Defining the Behavior of IoT Devices Through the MUD Standard: Review, Challenges, and Research Directions", in IEEE™ Access, vol. 9, pp. 126265-126285, 2021, doi: 10.1109/ACCESS.2021.3111477. [i.51] IEEE 802.11™: "IEEE Standard for Information Technology--Telecommunications and Information Exchange between Systems Local and Metropolitan Area Networks--Specific Requirements Part 11: Wireless LAN Medium Access Control (MAC) and Physical Layer (PHY) Specifications Amendment 7: Enhanced Broadcast Services", in IEEE Std 802.11bc™-2023 (Amendment to IEEE Std 802.11™-2020 as amended by IEEE 802.11ax™-2021, IEEE 802.11ay™-2021, IEEE 802.11ba™-2021, IEEE 802.11az™-2022, IEEE 802.11™-2020/Cor 1-2022, IEEE 802.11bd™-2022, IEEE 802.11bb™-2023, and IEEE 802.11™-2020/Cor 2-2024), pp.1-117, 28 February 2024, doi: 10.1109/IEEESTD.2024.10456575. [i.52] ECMA-368: "High Rate Ultra Wideband PHY and MAC Standard", 2007. [i.53] IEEE 802.15.3™: "IEEE Standard for Wireless Multimedia Networks", in IEEE Std 802.15.3™-2023 (Revision of IEEE Std 802.15.3™-2016) , vol., no., pp.1-684, 22 February 2024, doi: 10.1109/IEEESTD.2024.10443750. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 9 [i.54] ETSI EN 304 632: "CYBER; CRA; Essential cybersecurity requirements for smart home products with security functionalities; Including smart door locks, security cameras, baby monitoring systems and alarm systems". [i.55] ETSI EN 304 633: "CYBER; CRA; Essential cybersecurity requirements for Internet connected toys covered by Directive 2009/48/EC that have social interactive features (e.g. speaking or filming) or that have location tracking features". [i.56] Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys. [i.57] ETSI EN 304 634: "CYBER; CRA; Essential cybersecurity requirements for personal wearable products to be worn or placed on a human body that have a health monitoring (such as tracking) purpose and to which Regulation (EU) 2017/745 or Regulation (EU) 2017/746 do not apply; Or personal wearable products that are intended for the use by and for children". [i.58] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. [i.59] Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
2ba1876e0259e748d226a329803049d9	104 160	3 Definition of terms, symbols and abbreviations
2ba1876e0259e748d226a329803049d9	104 160	3.1 Terms	For the purposes of the present document, the following terms apply: commissioning: process in which the device boots and connects to the target security context, establishing the necessary security verifications and materials for operating within the context cyber intelligence: information gathering and analysis activity aimed at identifying, tracking/predicting capabilities and intentions/activities of hostile actors in the cybersecurity domain Cyber Threat Intelligence (CTI): evidence-based knowledge (including context, mechanisms, indicators, implications, and actionable advice) about an existing or emerging threat that can be used to make decisions regarding similar threats pre-provisioning: process in which the device undergoes initial configuration and security material installation during its first boot at the manufacturer's premises security lifecycle: continuous process that encompasses identifying, protecting, detecting, responding to, and recovering from cybersecurity threats zero-trust: approach that avoids inherent trust assumptions, but instead relies on the continuous evaluation and consideration of the entities' trustworthiness, e.g. for authorization processes
2ba1876e0259e748d226a329803049d9	104 160	3.2 Symbols	Void.
2ba1876e0259e748d226a329803049d9	104 160	3.3 Abbreviations	For the purposes of the present document, the following abbreviations apply: AAA Authentication, Authorization and Accounting ACL Access Control Lists ETSI ETSI TR 104 160 V1.1.1 (2025-10) 10 API Application Programming Interface ARM Advanced RISC Machines CA Certification Authority CAV Connected and Automated Vehicle CC Common Criteria CCS Connected Cabin System CERT Computer Emergency Response Team CERTIFY aCtive sEcurity foR connecTed devIces liFecYcles COPD Chronic Obstructive Pulmonary Disease COTS Commercial Off the Shelf CP-ABE Ciphertext Policy Attribute-Based Encryption CRA Cyber Resilience Act CSIRT Computer Security Incident Response Team CTI Cyber Threat Intelligence CVSS Common Vulnerability Scoring System DAA Direct Anonymous Attestation DID Decentralized IDentifiers DLT Distributed Ledger Technologies EAP Extensible Authentication Protocol ECU Engine Control Unit ENISA European Union Agency for Cybersecurity ERATOSTHENES sEcuRe manAgemenT of iOt deviceS lifecycle THrough idENtities, trust, and distributEd ledgerS EUCS European Cybersecurity Certification Scheme for Cloud Service GB Gigabytes GDPR General Data Protection Regulation GLOSA Green Light Optimized Speed Advisory HW HardWare IdM Identity Management IDS Intrusion Detection System IoC Indicator of Compromise IoT Internet of Things IoTSF IoT Security Foundation ISACs Information Sharing and Analysis Centers low-SWaP-C Size, Weight, Power and Cost MSPL Medium-level Security Policy Language MUD Manufacturer Usage Description NIS Network and Information Systems NIST National Institute for Standards and Technology OBU On-Board Unit OTA Over-The-Air PDP Policy Decision Point PEP Policy Enforcement Point PHG Personal Health Gateway PKI Public Key Infrastructure PP-CTI Privacy-Preserving Cyber Threat Intelligence PSTI Product Security and Telecommunications Infrastructure PUF Physical Unclonable Function RED Radio Equipment Directive SaaS Software as a Service SDC Statistical Disclosure Control SE Secure Element SESIP Security Evaluation Standard for IoT Platforms SIEM Security Information and Event Management SOAR Security Orchestration, Automation, and Response SOCs Security Operations Centres SSI Self-Sovereign Identity SW SoftWare TB Terabytes TEE Trusted Execution Environment TMB Trust Management and Broker TMRA Threat Modelling and Risk Assessment ETSI ETSI TR 104 160 V1.1.1 (2025-10) 11 UN United Nations URL Uniform Resource Locator V2I Vehicle-to-Infrastructure V2V Vehicle-to-Vehicle V2X Vehicle-to-Everything VC Verifiable Credentials VM Virtual Machine VP Verifiable Presentations W3C World Wide Web Consortium YANG Yet Another Next Generation
2ba1876e0259e748d226a329803049d9	104 160	4 Introduction
2ba1876e0259e748d226a329803049d9	104 160	4.1 Key IoT Security Challenges	The widespread adoption of Internet of Things (IoT) devices has introduced a complex security landscape. With a vast number of interconnected devices, the attack surface expands significantly, demanding robust security on both individual devices and the entire network. However, many IoT devices have limited processing power and memory, hindering the implementation of strong security measures. Additionally, the lack of built-in security features and outdated firmware make them susceptible to unauthorized access, data breaches, and manipulation. The heterogeneity of devices, protocols, and platforms interweaved in IoT scenarios leads to interoperability challenges and makes it difficult to establish consistent security processes. Weak regulations and the tendency of some manufacturers to prioritize functionality over security exacerbate these issues. Beyond these foundational challenges, securing IoT networks and devices requires addressing several critical areas, such as: • Security visibility: Security gaps are extremely hard to be detected, to remediate, and to address on time. This is especially true in IoT ecosystems as the large variety of devices, specifications, and vendors makes it difficult to gain clear views into their security posture. • Effective information sharing: The effectiveness of information sharing with incident response teams (CERTs/CSIRTs) falls short, hindering collective efforts to address threats. This compounds with other security challenges, as the complexity of the systems make the building of collective defences critical to achieve meaningful security levels. • Lifecycle management: IoT devices present specific challenges in terms of their lifecycle management (shown in Figure 1). A comprehensive solution should cover the distinct phases, from initial pre-provisioning of security mechanisms during device manufacturing, to its secure deployment, operation, and decommission in target systems. • Common trust enforcement mechanisms: Trust relies on the different expected behaviours of people, data, information, or processes. However, establishing trust is not easy in autonomous systems like IoT, and it becomes critical to be able to model, monitor and quantify trust and its related events in a way that can be understood by artificial agents becomes critical. • Identity and privacy framework: managing the identities of IoT devices presents challenges due to their hardware characteristics, autonomous functioning, and complex lifecycles. Current practices often lack information in terms of how device and user privacy is protected, and how this interacts with the security of the system through fine-grained access control. • Firmware updates: Firmware and security updates are infrequent, difficult, or even impossible in large IoT networks. The outdated firmware and exploitable vulnerabilities that attackers may leverage exacerbates the difficulty of addressing other security challenges. • Training and automated protocol adoption: Humans are the weakest point in the lifecycle chain, as they build, test, deploy and use IoT. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 12 Figure 1: Lifecycle phases
2ba1876e0259e748d226a329803049d9	104 160	5 ERATOSTHENES
2ba1876e0259e748d226a329803049d9	104 160	5.1 Overview	The ERATOSTHENES project tackles the complex security challenges of the IoT with a focus on managing the entire lifecycle of these networks through distributed trust management and digital identity solutions. The focal point is the development of a Trust and Identity Management Framework for IoT devices, distributed and operating across the entire network, addressing different steps of the lifecycle of the participant devices. Additionally, the framework is auditable, enabling transparent tracking and verification of actions. Finally, it is privacy-respectful, prioritizing user data privacy and control. By effectively managing the lifecycle of IoT devices, this framework aims to strengthen trust, identities, and overall resilience within the IoT ecosystem. Importantly, the framework is aligned with relevant regulations such as the NIS2 Directive [i.1], the GDPR [i.2], and the Cybersecurity Act [i.3], addressing topics such as CTI sharing for improved cyber-threat handling, privacy-aware identity management and data processing, or device cybersecurity profiles. Overall, the objectives of the project can be summarized as follows: • Design a reference architecture, components, and protocols for IoT lifecycle management, through the pillars of identity and trust in security domains, suited for resource-restricted environments, critical and industrial applications. • Design of a decentralized, scalable, efficient and privacy-preserving IoT identity management to conciliate the requirements of self-sovereignty and privacy preservation in a distributed, interoperable, and transparent trust model. • Design and development of a lightweight, distributed, and dynamic Trust Management solution to enhance the trust in large-scale distributed networks of heterogeneous IoT devices, covering each layer and cross-layer of the network. • Support the solution and build the overall governance layer of the trust network on novel Distributed Ledger Technologies, enabling decentralization of the solution within domains along with trustworthy information sharing (such as CTI data) in the whole ecosystem. • Integrate and validate the approach through real-world pilots relevant to the tackled challenges, namely intelligent transport systems, e-health scenarios, and Industry 4.0. • Deliver knowledge via dissemination and capacity building, supporting the enforcement of the Cybersecurity Act and standardization activities. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 13 5.2 ERATOSTHENES Architecture for IoT lifecycle management
2ba1876e0259e748d226a329803049d9	104 160	5.2.0 Introduction	Figure 2: ERATOSTHENES architecture The ERATOSTHENES architecture and concept have been carefully developed to be adaptable across multiple industrial domains. The architecture is designed to accommodate different use cases, specific requirements, and unique characteristics of each application environment. This flexibility enables its implementation in various scenarios, including transport infrastructures and vehicles, smart devices, personalized health devices, and more. The architecture envisions an environment with multiple independent (but potentially collaborating through information exchange) domains, serving to group operations depending on physical or logical criteria. The components related to the architecture will act within the device, pertain to a specific domain, or operate across multiple ones to enable global functionalities. ERATOSTHENES establishes identity management based on self-sovereign principles, with SSI Agents in devices managing credentials to enable security and privacy and supporting infrastructural components like SSI Management. Physical Unclonable Function (PUF) based authentication is considered to further enhance the security of identification and cryptographic fingerprinting. The Trust Management & Broker (TMB) groups key components for achieving a trust framework based on zero-trust principles. Devices will interact with the trust framework through Trust Agents and the TEE will be an anchor of trust for devices along with their identity. The TMB's components for IDS, monitoring, threat modelling, and risk assessment will perform the necessary monitoring and evaluation tasks for maintaining an updated trust network for devices. The use of services will require continuous authorization both through identity and trust policies, with the PDP and PEP serving to delegate the process to the domain infrastructure when necessary. Along with the identity and trust, the architecture also tackles the management of devices' lifecycles through supporting tools like those for backup, recovery, secure data storage, and management (actuation tools, management and recovery, data protector) and the use of MUD files and CTI sharing both for device's security configurations and coordinated responses to cyber-threats. The whole ecosystem is enabled by Distributed Ledger Technologies (DLTs) acting as verifiable data registries enriched with smart contracts. Particularly, specific information (such as related to CTI, identity, etc.) can be carried out across domains through inter-DLT to allow collaboration that helps achieve a global ecosystem with enhanced security. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 14 With this series of components, the architecture tackles challenges in the pre-provisioning, commissioning (or enrolment), and operational phases. In the former, providing a root of trust for the identification of the device, i.e. a root identity, and additional identity and security configuration data. Then, during commissioning these artifacts will be used to enrol a device in the security context of operation. The enrolment process enables privacy-preserving authentication and authorization processes, monitoring, and trust evaluation of devices during their operational phase. This is expanded in the following subsections.
2ba1876e0259e748d226a329803049d9	104 160	5.2.1 Pre-provisioning	The device undergoes initial configuration and security material installation during its first boot at the manufacturer's premises. This process has three key outcomes. First, the device receives and securely stores its root identity material, which serves as a foundation for authentication. This material can range from a simple pre-shared key (e.g. as used in EAP AAA) to a hardware-based root of trust for Trusted Execution Environments or advanced techniques like Physical Unclonable Function (PUF)-based fingerprints. Second, the device is provisioned with security-related configurations, including supported technologies and potential security profiles. Finally, device certificates are generated and installed, providing attributes that define the device's characteristics and identity. These certificates can be linked to the device's root identity, ensuring a secure and verifiable authentication process. Figure 3: Schematic view of fist pre-provisioning process In ERATOSTHENES, the Identity Management (IdM) solution uses Physical Unclonable Functions (PUFs) as the primary mechanism for device identification, acting as a root of trust for cryptographic fingerprinting. Figure 3 illustrates the initial pre-provisioning process. During this phase, the device undergoes PUF-based authentication enrolment, which involves installing a PUF authentication client and generating the corresponding cryptographic fingerprint. The device is then registered with the manufacturer's PUF authentication servers, establishing its root identity. Additionally, the device's security configurations are set up by creating an extended Manufacturer Usage Description (MUD) file. This file is stored on the manufacturer's MUD file server, and the device receives a URL linked to its identity through the PUF key material. Traditional identity certificates from PKI certification services are also installed, serving as an attribute source. The specific details of these certificates will vary based on the use case. For example, in scenarios like Intelligent Transport Systems, one of the project's pilots, the certificates may adhere to ETSI TS 103 097 [i.4]. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 15
2ba1876e0259e748d226a329803049d9	104 160	5.2.2 Commissioning	The next phase begins when the device first boots and connects to the target security context. To interact with the domain infrastructure, the device should perform a bootstrapping process that authenticates its root identity. The domain should have a trust relationship with the manufacturer, either directly through its identity service or implicitly, such as by trusting a public signing key. During this step, a domain identification key may be generated, acting as a root identity for use exclusively within the security context. Another important aspect of Identity Management (IdM) is enabling privacy-preserving authentication and authorization. In many use cases, authorization does not only require identification, but also the proof of certain identity attributes. Access control typically depends on conditions tied to these attributes. The framework follows self-sovereign identity principles, where subjects retain control of their identity. Therefore, the device's enrolment includes the issuance of credentials for attribute verification in the security context. This is done through identity proofs, typically in the form of certificates obtained during the initial manufacturer pre-provisioning. The final steps to be carried out during enrolment depart from the field of identity but are crucial for collaborative IoT scenarios and data spaces. Devices may publish their planned behaviour within the security context, such as offering services, data, or associated policies. This enables interactions during the operational phase and may influence how the authorization process is conducted. The result will be the full integration of the device into the trust management framework in the domain, enabling its monitoring and trustworthiness evaluation. Figure 4: Commissioning, enrolment in a security domain In ERATOSTHENES, the initial boot in the security domain (see Figure 4) is performed through the PUF authentication process. In this case, the process requires active involvement of the PUF authentication servers in the manufacturer's premises. As a result of this process, the device, through its SSI Agent, generates an identity for use within the domain and registers a Decentralized Identifier (DID) for identification. The SSI Agent interacts with issuers in the SSI Management infrastructure to facilitate the issuance process. This includes the identity proofing of the device, which may use the PKI certificates obtained by the device. After this, the device will have Verifiable Credentials (VCs) stored in its wallet. These VCs can be generated using a p-ABC scheme, that provides the opportunity for devices to later present them through the derivation of zero-knowledge proofs that reveal only the specific data necessary for an authentication process, improving the privacy achieved by the solution. To ensure secure usage and storage, the device's Trusted Execution Environment (TEE), particularly the Data Protector component, is used (note that sensitive material such as VCs or secret keys will be stored within the Data Protector, which is omitted from the diagram to avoid cluttering). At this point, the device has completed the identity enrolment process, but it may be necessary depending on the use case to link the device identity with the identity of its owner or manager within the domain (e.g. the security manager of a shop floor). ETSI ETSI TR 104 160 V1.1.1 (2025-10) 16 However, there is an additional process to complete the full enrolment within the ERATOSTHENES domain, involving the trust framework and particularly the Trust Manager & Broker. First, the security configurations are retrieved, analysed, and applied within the trust management component. This step initiates trust score calculations, risk assessment, monitoring, and other processes within the component. Note that the component is comprised of multiple subcomponents that will carry out the complex processes, such as Intrusion Detection Systems for monitoring, Risk Assessment and Threat Modelling engines, and a MUD Management module. The results, such as the initial trust score calculations and their rationale, are published on the DLT, which serves as the project's verifiable data registry.
2ba1876e0259e748d226a329803049d9	104 160	5.2.3 Operational Phase	Once the enrolment has been completed, devices are ready to interact with other entities in the security context. The framework defined in ERATOSTHENES follows the principles of self-sovereignty. That is, devices are in control of their identity materials, and no other parties should play an active role during an authentication process. As for the actual authorization, the project considers two scenarios that are common in practice. In both cases, the authentication check is equivalent: the device generates a Verifiable Presentation containing the information requested by the attribute-based policy. Outside the policy check, the process varies depending on who oversees verifying the result. On the one hand, the project envisions a fully decentralized approach, where the service provider is the one that assesses the requesting device. On the other hand, the service provider may delegate the authorization check to the infrastructure with the traditional roles of Policy Decision Point (PDP) and Policy Enforcement Point (PEP). Slight variations, like the service provider acting as its own PEP, are easily adapted from the framework. The main advantage of the centralized approach is that the more resource-intensive authorization process is carried out less frequently, with the verifier delegating the task to the infrastructure. This enables service providers with limited resources, or those that prefer to rely fully on the infrastructure, to integrate seamlessly into the framework. Additionally, it maintains backward compatibility with many existing IoT scenarios that already use a PDP/PEP infrastructure. However, this approach places a greater burden on the server-side and diverges from decentralization, as it requires stronger trust assumptions in the infrastructure. Despite this, both approaches can typically coexist, offering a range of viable options. Figure 5: Service usage authorization check ETSI ETSI TR 104 160 V1.1.1 (2025-10) 17 Figure 6: Service usage decentralized authorization alternative schematic view Thus, in ERATOSTHENES (see Figure 5) devices can perform authentication/authorization processes using the VCs retrieved during enrolment. Participants can retrieve policies from the DLT and generate Verifiable Presentations (VP) that include the necessary information to fulfil the policy through their SSI Agent. Additionally, they may check the current trust evaluation of the target service to inform the decision on continuing with the process or not. Due to the p-ABC scheme, the authentication process can be done in a zero-knowledge fashion, ensuring minimal disclosure and non-link-ability of the revealed data. By generalizing the process by enabling the PDP to generate authorization tokens that are valid for the mid to long term, reducing the frequency of complete authorization processes. These tokens are then checked by the PEP when accessing a service. Alternatively, the use of a direct communication flow is also supported by the solution, as shown in Figure 6. In both cases, according to the zero-trust approach of the framework, the current trust score of the involved parties is checked as an additional source of information for authorization decisions. The DLT plays the role of a verifiable data registry for identity and trust information, serving as a decentralized enabler for the trustworthiness in the process. Note on flexibility of the presented flows: The previous subsections present a solution covering the steps identified in the ERATOSTHENES framework up to device's actively participating in the domain. Throughout the discussion, it has established specific solutions, but it is worth noting that there exist alternatives with trade-offs. For instance, the adoption of a full-fledged p-ABC scheme brings remarkable privacy advantages but also introduces limitations e.g. in terms of efficiency. In some scenarios, selective disclosure might be enough to cover the privacy requirements. In other cases, it might not be possible to rely on schemes more complex than plain forwarding of credentials because of limiting resource constraints of the involved devices. Similarly, PUF-based authentication gives high guarantees against forgery or attacks on devices but imposes strict requirements on hardware that simpler solutions like pre-shared keys or plain certificates avoid. This need for flexibility is not only important for instantiations of the framework in different use cases. The vast heterogeneity within IoT environments in terms of conditions or device types makes the flexible application of technologies a key requirement in every deployment. Otherwise, solutions will achieve poor security or privacy results or become impractical as many devices will not be able to participate. This means the ideas of protection profiles enforced for specific targets (ISO/IEC 15408-1 [i.49]) are a compelling avenue for comprehensive solutions. It enables the creation of "flavours'' of security/privacy, which will be applied depending on the characteristics or needs of each device and domain of use. Accordingly, while the flows presented are the main solution in the ERATOSTHENES architecture, some variations are foreseen and planned. Precisely, the application of specifications such as the W3C VCs allows organizations to achieve transparent interchangeability between different solutions that offer trade-offs on security, privacy, and efficiency during an attribute-based authorization process without changes to flows, implementations, or models. Similarly, not all devices will be PUF-enabled, so alternative approaches for the root identity like pre-shared keys may be considered as an alternative. In this sense, the zero-trust approach of the framework helps to accommodate such changes more smoothly. The device's trustworthiness will be continuously evaluated and considered for authorization. Particularly, during enrolment, their characteristics and supported technologies will be considered to assign trust scores. A key tool for moving towards the security profile paradigm and aligning with Cyber Resilience Act (CRA) [i.20] is the extended MUD files, which can be assigned to each device to establish some security configurations that will be considered during enrolment and operation (see clause 9 for more information). ETSI ETSI TR 104 160 V1.1.1 (2025-10) 18 Particularly, the recovery processes in ERATOSTHENES cover multiple scenarios related to a device's lifecycle such as partial compromise or malfunction, actuations against potential threats even before they are realized, or substitution for a new device. The process may be triggered internally by the monitoring tools, or coming from the threat and mitigation sharing framework of the project as expanded in clause 7. Then, depending on the specifics of the issue, a multi-stage recovery process will be carried out. First, if necessary, new software will be securely deployed on the device (e.g. an upgraded version of a firmware that patches a known vulnerability). Then, recovery of identity material will be carried out, protected through the use of Data Protector and advanced cryptographic techniques such as proxy re-encryption. Lastly, the trust context of the device within the security domain will be updated and configured in the device to ensure its readiness to participate in the domain as part of its operation. The DLT is used as a verifiable registry to support these processes in a decentralized way. Figure 7: Generic device recovery process
2ba1876e0259e748d226a329803049d9	104 160	6 CERTIFY
2ba1876e0259e748d226a329803049d9	104 160	6.1 Overview	The Horizon Europe project CERTIFY (active security for connected device lifecycles) aims to provide a methodological, technological, and organizational framework that ensures security throughout the lifecycle of connected devices. These efforts align with current EU regulations, particularly the CRA, positioning the project to not only demonstrate compliance but also to address real-world security challenges. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 19 CERTIFY's goal is to provide to IoT stakeholders (e.g. auditors, manufacturers, users, Information Sharing and Analysis Centers (ISACs), with tools and strategies that foster a high level of security. The project takes a collaborative and decentralized approach, helping stakeholders identify, assess, and respond to security threats throughout the lifecycle of connected devices. A key point of the CERTIFY approach is the sharing of security information and evidence among relevant parties, allowing for continuous risk assessments and faster responses to new vulnerabilities. CERTIFY's methodology addresses the full lifecycle of connected devices - from initial design and risk assessment to secure decommissioning or repurposing. Rooted in the principle of security by design [i.46], [i.47], the approach integrates security protocols and cryptographic controls from the beginning. By embedding these measures early in the design and development phases, CERTIFY ensures that devices are equipped to resist threats before they are deployed. After deployment, the framework supports secure commissioning, continuous monitoring, and adaptive reconfiguration to preserve device integrity and resilience against emerging vulnerabilities. This proactive strategy reduces real-time risks and limits the need for costly, reactive fixes.
2ba1876e0259e748d226a329803049d9	104 160	6.2 CERTIFY Framework
2ba1876e0259e748d226a329803049d9	104 160	6.2.0 Introduction	The CERTIFY architecture, as depicted in Figure 8, is organized into six "domains" or "planes" with dedicated functionalities. The embedded device plane provides security services built on top of hardware functionalities to instantiate and maintain a secure environment. It characterizes the IoT platform through the CERTIFY API and services, including for instance support for operations such as configuration, bootstrapping, upgrading, and monitoring. These high-level services are offered by the low-level security enablers for the IoT device, the Secure Element (SE) [i.32] and the Trusted Execution Environment (TEE) [i.33]. The access to such enablers is abstracted and made accessible through a low-level API. Figure 8: CERTIFY Architecture ETSI ETSI TR 104 160 V1.1.1 (2025-10) 20 The Domain enforcement plane includes services for the secure deployment of the device within the domain and the application of updates on the device. One core component of this plane is the Secure Enrolment module, responsible for the registration of the devices in the domain and the issuance of cryptographic material as the basis for domain identities. The secure update and upgrade agent provides a graphical user interface where security administrators can visualize registered software and devices, upload the software to the repository, and trigger the secure Over-The-Air (OTA) software update process. The Domain orchestration plane provides coordination functionalities within the domain, and its main component is the Device and Domain Manager, that provides high-level management IoT devices within a security domain. In particular, it coordinates the enforcement and reconfiguration of IoT devices. All the configurations (e.g. policies applied, version of updates) are stored in the Inventorying and Registry, which provides trustworthy data storage e.g. through DLTs. The Domain runtime sensors and monitoring plane offers software-based solutions for monitoring, detection, and decision functionalities based on the information received from the device and other domain components. The Network Bootstrapping Monitor and the Intrusion Detection System (IDS) receive data from the CERTIFY API in the IoT device regarding the network activity in different phases of the lifecycle (bootstrapping and operation). Alerts are sent to the SIEM-SOAR (Security Information and Event Management - Security Orchestration, Automation and Response), which aggregates data and carries out complex analysis. The Cyber Threat Intelligence (CTI) plane provides services for ensuring privacy-preserving sharing of security information, such as vulnerabilities, mitigations or recommended configurations. The Privacy-Preserving CTI (PP-CTI) system is a central tool here, anonymizing sensitive data and attributes in cyber threat reports. For responding to identified threats, the CTI plane combines the MUD [i.7] with the Threat MUD server [i.11] respectively as default secure configuration, and threat and mitigation signalling mechanisms. Finally, the external plane integrates all the manufacturer services that, even if not strictly part of the framework, are exploited by CERTIFY. In particular, it includes services for security assessment and certification, CTI sharing, device authentication, and MUD generation and storage.
2ba1876e0259e748d226a329803049d9	104 160	6.2.1 Pre-provisioning
2ba1876e0259e748d226a329803049d9	104 160	6.2.1.1 Design Phase	In this phase, the device is designed, developed, programmed, and tested, establishing its initial security posture. All actors in the supply chain - component designers, integrators, and software developers - are involved, while the manufacturer conducts the initial security evaluation. However, as new threats and vulnerabilities continue to emerge, defining a fixed, standardized cybersecurity evaluation and certification process becomes increasingly difficult. This evolving threat landscape demands agile and dynamic approaches to maintain product security throughout its lifecycle. As a result, continuous assessment and the use of dynamic labels that reflect a device's current security status in real time are essential. While current certification schemes [i.48] acknowledge this need for adaptability, frameworks like Common Criteria (CC) [i.5] still require full recertification for any security change, leading to significant time and financial costs [i.34]. To support security by design and enable dynamic certification, CERTIFY proposes a model-based evaluation and certification approach. This method allows security to be tested from the early design stages and supports automation of the evaluation process by integrating security testing with risk assessment. The approach is implemented through the Cyberpass tool (https://www.cyber-pass.eu/) - a cloud-based platform that interprets security requirements and guides the evaluation process. It begins with a self-declaration or self-assessment step, enabling manufacturers to respond to a tailored questionnaire based on relevant security criteria. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 21
2ba1876e0259e748d226a329803049d9	104 160	6.2.1.2 Pre-provisioning of security material	While security assessment results are typically used only for device certification, CERTIFY leverages this information to enhance device deployment and operation. Specifically, the evaluation results are embedded into a behavioural profile that maps different security levels to recommended operational policies. This profile limits the device's behaviour to a defined set of actions, thereby reducing its attack surface and enabling the detection of anomalous activity during runtime. CERTIFY's behavioural profile extends the Manufacturer Usage Description (MUD) standard [i.35] and [i.36]. The extended MUD profile is digitally signed by the Certification Authority (CA) and hosted on a MUD server, making it accessible to clients that buy and deploy the device. The MUD URL and root cryptographic identity material are stored in the device to facilitate secure deployment. To support this process, CERTIFY utilizes strong isolation mechanisms - such as Secure Elements (SE) and Trusted Execution Environments (TEE) - enabled by open hardware architectures and trusted computing standards.
2ba1876e0259e748d226a329803049d9	104 160	6.2.2 Commissioning	The commissioning phase starts when the device is installed and configured in a certain context. This usually consists of a set of procedures in which a device joins a network in a certain security domain. During the process, the cryptographic material installed during the previous phase is used to derive dynamic credentials and keys to be used during its operation. Extended MUD files were integrated into CERTIFY's enhanced commissioning to enable the safe deployment of configurations prior to the device joining the domain. Therefore, the device will not be allowed to interact with other components or to access network resources until it is not properly identified, configured, and authenticated, ensuring that the network will not be compromised once the device will access to it. In the first stages, the device requests to start the bootstrapping in the domain. CERTIFY leverages the Extensible Authentication Protocol (EAP) [i.25] to authenticate the device and generate domain keys. Moreover, CERTIFY relies on the extended MUD of the device, which is securely retrieved and translated in the MUD manager during the authentication process, to securely configure the device. The results are used during the security configuration of the device. Additionally, CERTIFY also checks that the device type is authorized based on its fingerprint. While attempting to join an IoT network, each device type exhibits a characteristic fingerprint. The network bootstrapping monitor exploits such a behavioural feature of the device to build a monitor that can pose constraints on the devices that can join the network, as well as request the enforcement of specific rules. This behavioural fingerprint can be created by the manufacturer and included as part of the extended MUD file designed in CERTIFY. For completing the enrolment in the domain, high-end devices need to verify their correct state based on the policies defined in the MUD. CERTIFY leverages the DAA (Direct Anonymous Attestation) protocol to authenticate the high-end device and generate appropriate policies for attestation. The DAA allows verifying the correct state of the device based on this verifiable evidence and helps to decide whether the network should allow or not the device to join. Once deployed, the device can generate dynamic credentials based on its identity for securely communicating with the entities inside the domain. All the information about authorized network devices, configurations, identity certificates and upgrades are stored in the Device Inventory and Registry.
2ba1876e0259e748d226a329803049d9	104 160	6.2.3 Operational Phase
2ba1876e0259e748d226a329803049d9	104 160	6.2.3.0 General	In the operational phase, continuous monitoring of the device is essential due to evolving security threats and vulnerabilities that were not anticipated at design time. As a device's security posture evolves, it may require reassessment and even recertification. Within the CERTIFY framework, monitoring components collect data from IoT devices to detect vulnerabilities and trigger appropriate mitigation actions. Runtime attestation and the Integrity Monitor verify that certified security properties are maintained, while an IDS analyses network traffic in real time to identify potential threats. Detection rules are regularly updated with new signatures and can be tailored to specific user or customer needs. More complex analysis is handled by the Security Information and Event Management (SIEM) - Security Orchestration, Automation, and Response (SOAR) component, which processes events from both the network and the device, correlating them to detect sophisticated threats. The Device and Domain Manager then coordinates enforcement of mitigations and updates, linking runtime detection to recommended actions from manufacturers, threat databases, or certification authorities. CERTIFY uses an extended Threat MUD to support this process, enabling the system to block network access or reconfigure the device in response to critical risks. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 22 CERTIFY fosters continuous information sharing among stakeholders. It integrates external intelligence on vulnerabilities, patches, and zero-day threats with domain-specific insights. This is done through the Privacy-Preserving CTI (PP-CTI) component [i.37], which securely shares data with manufacturers and Cyber Threat Intelligence (CTI) providers, enabling bidirectional exchange of alerts, threat information and even mitigation actions.
2ba1876e0259e748d226a329803049d9	104 160	6.2.3.1 Updating	Over-The-Air (OTA) software updates are vital for maintaining the long-term security of IoT devices. This need is underscored by standards and recommendations from organizations such as the European Union Agency for Cybersecurity (ENISA), which highlights regular updates as key to improving the security and reliability of connected systems [i.38], [i.39] and [i.40]. CERTIFY aligns with these recommendations by incorporating OTA components based on the IETF RFC 9019 [i.6] framework. To strengthen security and trust, CERTIFY integrates DLTs to log every event related to firmware updates and device metadata. This provides transparency, immutability, and a continuous chain of trust across the OTA process. Secure cryptographic algorithms are used to verify firmware integrity and sign updates, ensuring authenticity and protection against tampering. The update phase in CERTIFY includes both the deployment of software patches from manufacturers and configuration adjustments needed to counter emerging threats. These tasks are carried out by a coordinated set of components - such as the enforcement and reconfiguration agent, secure update and upgrade agent, and the device and domain manager - and may be initiated manually by administrators or automatically in response to detected threats or anomalies.
2ba1876e0259e748d226a329803049d9	104 160	6.2.3.2 Decommissioning & Repurposing	The decommissioning phase in the CERTIFY lifecycle marks the final stage of a connected device's life, where it is either retired from operations or repurposed. This phase is crucial to ensuring that devices no longer in service do not pose residual security risks. Proper decommissioning protects the network by securely managing all sensitive data and configurations, preventing potential vulnerabilities that could arise from improper disposal. The process begins with an assessment to determine whether the device can be safely repurposed for a less security-sensitive role or should be fully retired. For devices being decommissioned, CERTIFY prioritizes secure data erasure - permanently deleting cryptographic keys, certificates, logs, and configurations. To ensure transparency and policy compliance, the framework uses DLT to create a verifiable, immutable record of the decommissioning process. If a device is deemed suitable for repurposing, CERTIFY provides a secure reconfiguration framework. This may involve assigning the device to a lower-security domain or adjusting its functionality to handle less sensitive tasks. While repurposing can extend device lifespan and reduce costs, it should be done in a way that maintains appropriate security standards for the device's new role. 7 Design of the continuous cybersecurity posture management and relation to CRA and certification
2ba1876e0259e748d226a329803049d9	104 160	7.1 Introduction	In both projects, two technologies rise as a key cornerstone for achieving the continuous cybersecurity posture and certification goals. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 23
2ba1876e0259e748d226a329803049d9	104 160	7.2 Manufacturer Usage Description (MUD)
2ba1876e0259e748d226a329803049d9	104 160	7.2.0 General	To achieve effective detection and mitigation of security threats in specific IoT environments, it is useful and sometimes necessary to know the expected behaviour of devices beforehand. However, the heterogeneity of IoT environments (from critical infrastructures to home) and of devices themselves, based on various technologies and communication protocols, and the restrictions inherent to certain IoT devices (e.g. the lack of a user interface) make the management of IoT devices cumbersome for non-expert users. To cope with these challenges, one key aspect is to standardize the identification and management of device behaviour. The Manufacturer Usage Description (MUD) standard was published in 2019 by the Internet Engineering Task Force (IETF) [i.7]. The MUD specification's major goal is to limit the threat and attack surface of a certain IoT device by allowing manufacturers to establish network behaviour profiles for their devices. Each profile is specified through Access Control Lists (ACLs), which establish policies for communication endpoints. They are defined using Yet Another Next Generation (YANG) [i.8] to model network restrictions, and JavaScript Object Notation (JSON) [i.9] as the serialization format. Since its adoption, MUD has been the object of interest both from researchers and standardization bodies. In particular, the National Institute of Standards and Technology (NIST) and the European Union Agency for Cybersecurity (ENISA) consider the use of MUD as part of future IoT security good practices to increase security against cyberattacks in IoT domains. The protection of security in environments with IoT devices does not end with the initial device installation. Many vulnerabilities and attacks can, and indeed are, discovered during the operational phase. For instance, only in 2022, more than 25,000 vulnerabilities were detected [i.10]. Manufacturers cannot always deal with vulnerabilities quickly enough through updates, which follow a complex process, and in many cases the relationship with third-party services makes this even harder. While MUD files can be updated, this process does not cover most vulnerable scenarios. In this sense, security-information-sharing systems enable fast and collaborative sharing, and analysis and mitigation of vulnerabilities or attacks, which may also be applied before a patch is released. The sharing of cyber-threat information for building cybersecurity capabilities has also been a big focus of the NIS2 Directive of the ENISA [i.1]. In this direction, the NIST proposed a threat Manufacturer Usage Description (threat MUD) [i.11], to share vulnerability information and its mitigations. It is based on the MUD standard for device behaviour specification and follows a similar structure. However, despite the close relationship, the threat MUD is conceived as a mitigation mechanism. However, the NIST only gives some indications about the threat MUD model and its functioning, leaving some details undefined but framed in the guidelines. In the following clause, the present document overviews the threat MUD model as presented in [i.12], which the present document uses as a basis, though with differences on how the flows are integrated into the architecture (e.g. receiving threat identifiers for which to search associated files through the TMB). The present document takes NIST guidelines and the MUD standard as a starting point. A key element to have in mind for the threat MUD is that, even if its structure and operation are similar that of the regular MUD, its purpose is to serve as a mitigation method against a specific threat, particularly through network communication rules for sites that have been associated to a threat. Therefore, a threat MUD does not need to be strictly related to a specific device, nor specify expected behaviour. As a result, rather than being developed by the manufacturer, the threat MUD might be created by a threat intelligence provider. As with the standard MUD, the threat MUD model has two modules. The first module reflects information about the threat MUD itself. It contains equivalent fields to the MUD standard, such as version, URL, cache-validity, signature, etc. However, some fields have to be modified (manufacturer name is changed to intelligence provider, and device model name is changed to threat name), removed (information about device to which the MUD is associated like system or firmware is no longer needed), or added (CVSS and documentation fields for additional information about the threat) to fulfil the new mitigation goal. The second module is again related to the ACLs that specify the conditions and restrictions. In this case, as the file is tied to a threat and its mitigation and not to a specific device, the configuration to apply should be as generic as possible. Thus, unnecessary fields like "same-manufacturer", "local-networks", "controller", and "my-controller" (which established conditions specific to the device) are removed. MUD is integrated into ERATOSTHENES and CERTIFY as a source of behavioural information of the devices that enrol in a domain. The MUD file servers are outside of the end user domains, e.g. on the manufacturer premises. MUD components from all domains may communicate with them to retrieve MUD files. The main functional components of the MUD standard and threat MUD proposal will be active in each domain, as part of the Trust Manager & Broker component. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 24
2ba1876e0259e748d226a329803049d9	104 160	7.2.1 Key Components of MUD	• MUD File: This file, created by the manufacturer, contains a detailed set of instructions that define the anticipated network behaviour of the device. It serves as a blueprint for the device's network interactions and security posture. • MUD Manager: This component acts as the network administrator. It is responsible for retrieving MUD Files using MUD URLs provided by the devices. The MUD Manager ensures that the network policies are updated according to the latest MUD specifications. • MUD URL: Embedded within the device by the manufacturer, this URL points to the location where the MUD file is stored. It allows the MUD Manager to fetch the necessary files for policy implementation.
2ba1876e0259e748d226a329803049d9	104 160	7.2.2 Extended MUD	The MUD standard [i.50] presents a few limitations to its capabilities and applicability in practice, such as reduced expressivity focused only on networking, insufficient security in the MUD retrieval process, or supporting efficient updates for security information. Both ERATOSTHENES and CERTIFY go beyond the standard and provide "extended MUD", addressing such gaps for an improved impact of the solution in the lifecycle management process. CERTIFY extends the MUD model to accommodate finer-grained security aspects and diverse security policies. These encompass extended network access control, channel protection, data protection, and authorization policies [i.36]. In this regard, while a standard MUD server offers guidelines for allowed or restricted network activities for each device, a Threat MUD server would allow to incorporate real-time or near real-time threat information as provided by the PP-CTI. Additionally, the extended MUD file is taking advantage of to include behavioural profiles and device fingerprints that can be later used for attestation and monitoring of the device during the initial phases and throughout its operation in a security domain. One of the key innovations in ERATOSTHENES over the standardized MUD obtaining process comes from the integration of the MUD processing into a full-fledged trust framework. Now, using the ERATOSTHENES domain enrolment phase to get the MUD URL from the device, through the publish/subscribe approach used for communication between TMB components. The integration in such a flow, and within the ERATOSTHENES ecosystem, also allows the exploration of further improvements for the MUD flow. For instance, while the communication with the MUD fileservers can be easily secured in any usual way for webservers (e.g. HTTPS), there is a glaring gap in the standard regarding the possible spoofing of a MUD URL by the device. This authentication of the URL during MUD file obtention can be tackled through the ERATOSTHENES identity framework. Specifically, the manufacturer (at pre-provisioning time, along with PUF and MUD URL installation) will associate the PUF of a device (as a root of trust for identity) to the respective URL. Alternative approaches can be explored in the case of not having PUF available as a root of trust, following the project's general approach for tackling this case, e.g. by taking it into account when threat models, risk and trust for the device are evaluated. This is addressed, for instance, in CERTIFY with the securitization of the process through the secure element of the device during the bootstrapping phase. Of course, network elements will still have to be considered in specific instantiations, but this will be partly solved by the own MUD mechanism: MUD files will be associated to devices that are relevant to the application domain, which will make the rules included in them relevant to the deployment domain by default. What is more, the advantages of the extension of the MUD model with higher-level concepts, like software updates or cryptographic parameters restrictions, will be even more relevant through this abstraction. Lastly, both projects tackle the issue of efficient and scalable MUD updates and the dynamicity of security contexts, with the inclusion of update flows, threat MUDs and other means for sharing threat information. The approach taken in the projects for lifecycle management through MUD files thus innovates by providing comprehensive mechanisms at multiple levels (e.g. not only network level, or one-time configurations) that tackle multiple challenges identified in the MUD standard and other recent works and ensure the continuous management throughout the lifecycle including collaboration through sharing of cybersecurity information from many sources. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 25
2ba1876e0259e748d226a329803049d9	104 160	7.2.3 MUD management in ERATOSTHENES
2ba1876e0259e748d226a329803049d9	104 160	7.2.3.0 General	Figure 9: Instantiation of MUD components in ERATOSTHENES As a detailed example of the described tools and processes, Figure 9 shows the instantiation of the MUD components in the ERATOSTHENES architecture. Note that the MUD management module in ERATOSTHENES is an aggregation of subcomponents, including the functionalities of both standard MUD and threat MUD managers, plus a translation module for the interaction with other ERATOSTHENES components, e.g. by transforming MUD files into corresponding security policies.
2ba1876e0259e748d226a329803049d9	104 160	7.2.3.1 MUD Manager / Threat MUD Manager	The central components of the MUD Management Module architecture. The MUD Manager oversees the retrieval of MUD files associated to devices that enrol in an ERATOSTHENES domain. The threat MUD manager carries out the equivalent functionality for threat MUD files.
2ba1876e0259e748d226a329803049d9	104 160	7.2.3.2 Policy Translator	For inter-component communications, ERATOSTHENES introduces a service to translate MUD files into intermediate security policies. ERATOSTHENES currently utilizes Medium-level Security Policy Language (MSPL) [i.13], a security policy language with medium level of abstraction, that provides a set of actions suitable by the most common applicable security settings. The MSPL's structure is defined in a YANG model, which allows using XML or JSON as encoding format. This allows flexibility when applying the information contained in MUD files. Other components will take the medium-level policy from the topic and take advantage of it for their purposes, potentially with another translation into their own structures. For instance, the TMRA may use the policy directly to increase its knowledge base for building models, while the IDS may translate policies into rules that detect related events and further enforcement policies may be derived by PDPs.
2ba1876e0259e748d226a329803049d9	104 160	7.2.3.3 MUD File Servers	The source for all MUD/Threat MUD files. MUD file servers are located outside the ERATOSTHENES deployment, belonging instead to the device manufacturers. MUD components from all domains may communicate with them to retrieve MUD files. Threat MUD file servers, on the other hand, are controlled by threat intelligence actors (which may not necessarily be manufacturers). ETSI ETSI TR 104 160 V1.1.1 (2025-10) 26
2ba1876e0259e748d226a329803049d9	104 160	7.3 Continuous Assessment	In today's interconnected digital landscape, cybersecurity is no longer an afterthought; it is a strategic imperative. Organizations should proactively defend against cyber threats, adapt to evolving attack vectors, and ensure the resilience of their systems. This is critical to achieving cybersecurity resilience in the face of constant risks and threats. Referring to the cybersecurity environment, an organization's continuous efforts to monitor, assess, and improve its security measures are necessary. Unlike a static approach, where security is treated as a one-off event, the continuous posture recognizes that threats are dynamic and require constant vigilance. The following key components are recognized: • Threat Intelligence: Organizations collect and analyse threat intelligence to stay informed about emerging risks. This includes monitoring vulnerabilities, tracking threat actors, and understanding attack patterns. • Security Monitoring: Real-time monitoring of network traffic, system logs, and user behaviour helps detect anomalies and potential breaches. Security Operations Centres (SOCs) play a crucial role in this process. • Incident Response: Having a well-defined incident response plan ensures that the organization can swiftly address security incidents. Timely detection, containment, eradication, and recovery are essential steps. • Patch Management: Regularly and consistently applying security patches and updates is fundamental. Unpatched vulnerabilities are often exploited by attackers. • Employee Training: Educating employees about security best practices reduces the risk of insider threats and social engineering attacks. The European Union's Cyber Resilience Act (CRA) aims to protect consumers and businesses that buy or use products or software with a digital component. This law establishes mandatory cybersecurity requirements for manufacturers and retailers of such products, ensuring that inadequate security features become outdated. The CRA addresses two key issues: • Inadequate level of cybersecurity: Many products have an insufficient level of inherent cybersecurity or poor security updates. The CRA establishes harmonised standards when placing products or software with a digital component on the market. • Inability to determine secure products: Consumers and businesses are often unable to determine which products are secure from a cyber perspective. The CRA introduces a framework of cybersecurity requirements that governs the planning, design, development, and maintenance of such products. More descriptions on these regulations and needs, and how ERATOSTHENES and CERTIFY technologies may be envisaged as a tool to address them can be found in clause 9 of the present document.
2ba1876e0259e748d226a329803049d9	104 160	7.4 Cyber Threat Intelligence (CTI)
2ba1876e0259e748d226a329803049d9	104 160	7.4.1 General	Cyber intelligence is an information gathering and analysis activity aimed at identifying, tracking/predicting capabilities, and intentions/activities of hostile actors in the cybersecurity domain. Cyber-Threat Intelligence (CTI) can be defined as evidence-based knowledge (including context, mechanisms, indicators, implications, and actionable advice) about an existing or emerging threat that can be used to make decisions regarding similar threats. CTI is a compound of attributes that give overall meaning to such a report, e.g. malicious IP addresses or hashes alone are not considered CTI but grouped in context along with other information to form part of a CTI report. One of the most crucial elements of Cyber Threat Intelligence are Indicators of Compromise (IoCs). They are the most easily actionable attributes and the ones that most tools working with this information focus on: IoCs are widely used in applications such as Intrusion Detection Systems, web blockers, identification of compromised hosts or malware. In addition, these indicators can be easily related to other indicators that have occurred previously, taking advantage of big data analysis techniques on stored indicators. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 27 There are some risks involved in sharing CTI. Organizations are reluctant to share information on such platforms because they feel that revealing information about intrusions could damage their reputation. Moreover, this information sometimes carries identifying data, IP addresses, email accounts, names, which in the hands of attackers can be used against the organization that shared it, if they have not fixed the breaches in their system yet. This information, also, can fall into the hands of a dishonest partner, who can make fraudulent use of the data. For the anonymization of these identifiers values, there exist privacy-preserving and data transformation techniques, such as suppression, generalization, sampling, k-anonymity, l-diversity, t-closeness, d-presence, etc., derived from Statistical Disclosure Control (SDC) [i.14]. SDC, also known as Disclosure Avoidance, is the discipline that manages the balance between the privacy of respondent data and the usefulness of this data for research purposes. These techniques attempt to minimize data risks related to identity disclosure, (i.e. when an adversary can correctly associate an individual within a dataset), attribute disclosure, (i.e. when an attacker is able to infer the value of an attribute due to the distribution of attribute values in the table) and membership disclosure, (i.e. the ability of an attacker to be able to determine at very high probability whether or not a particular individual is in the dataset).
2ba1876e0259e748d226a329803049d9	104 160	7.4.2 CTI in ERATOSTHENES	One of the key business challenges for IoT scenarios is the need for increased cybersecurity, as security events incur in many direct and indirect losses. The components developed in ERATOSTHENES and CERTIFY aim to provide a platform for inter-domain Cyber-Threat Intelligence (CTI) sharing, compliant with the guidelines of the NIS directive. The main outcome is the collaboration of the tools developed for a comprehensive scenario that covers the needs for CTI sharing in heterogeneous and large IoT scenarios. To showcase these concepts, this clause provides a detailed description of the CTI sharing components in ERATOSTHENES. ERATOSTHENES supports a comprehensive, resource-efficient, and flexible security analysis of threats based on cyber intelligence sharing across the different domains. The objective is to maintain an update status about vulnerabilities and threats that appears through the architecture elements including the lifecycle management and the trust governance layer. To this end, CTI reports will be generated by monitoring entities and shared through the domains with the support of the inter-DLT infrastructure. The exchange of security and threat information between the various stakeholders is implemented through CTI integration into DLT and inter-DLT platforms. The CTI Sharing Agent is a key component in the process of communication and threat information sharing between domains, specifically CTI and IDS systems. Besides, its anonymization techniques and along with the MISP platform ensure privacy and reliability, and flexible encryption approaches such as CP-ABE, in addition to privacy-enhancing techniques like k-anonymity or t-closeness provide confidentiality, trust, and privacy enhancement. This approach should provide the necessary confidentiality and flexibility for the tracking and exchange of cyber threat information. Figure 10 shows the detailed description of the CTI Sharing Agent as part of a Trust Manager and Broker, as well as the main communication flows between the subcomponents, and with other ERATOSTHENES components. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 28 Figure 10: CTI Sharing Agent structure and flows The information shared through the CTI agent is integrated into the ERATOSTHENES ecosystem through the Trust Manager and Broker. A specific topic is setup so that components interested in threat information will receive the relevant events. One component of particularly close relationship with the CTI sharing tool is the Intrusion Detection System (IDS). The events generated by the IDS after detection of security events are shared with the CTI sharing agent through the MQTT broker. This is received by the CTI Agent Connector, which parses and prepares it and sends it to the next step in the pipeline, the Anonymizer, from which the events processed according to privacy policies are published. From the other direction, events received in the CTI agent from other agents will be prepared and published to the MQTT broker by the CTI Agent Connector. The IDS will be able to use that information to improve its detection capabilities, for instance by including rules in its detection engine that cover the newly discovered events. Another component whose interaction with the CTI Agent brings important security gains is the MUD Management module. One key element that may be shared through CTI are events that convey the publication of new mitigations, particularly new Threat MUD files, by manufacturers or security teams. Thus, the MUD Management module can retrieve them, translate them into a Medium-Level Security Policy Language (MSPL) object that is shared through the MQTT broker so that mitigations can be applied by the ERATOSTHENES components.
2ba1876e0259e748d226a329803049d9	104 160	7.4.3 CTI Sharing Agent Components
2ba1876e0259e748d226a329803049d9	104 160	7.4.3.1 CTI Agent Connector	This component handles communication with other components of the TMB by subscribing to the broker's threat sharing MQTT topic. The CTI Agent Connector receives threat alerts coming from the Monitoring IDS component. It also retrieves events from the MISP instance for later forwarding them to TMB components through the MQTT broker. Lastly, it governs the authorization of sharing processes with CTI Sharing Agents from other domains, relying on the project's identity management solution (e.g. authentication through DIDs).
2ba1876e0259e748d226a329803049d9	104 160	7.4.3.2 Anonymizer	Receives a threat-related event coming from the CTI Agent Connector and applies anonymization techniques that are specified in the privacy policy file related to that type of event. After the anonymization process the resultant event is published on the MISP domain's instance, and additionally, the DLT is used for auditability and signalling of this publication process. The techniques implemented in this component are generalization, suppression, k-anonymity, l-diversity, and noise addition via Differential Privacy. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 29
2ba1876e0259e748d226a329803049d9	104 160	7.4.3.3 MISP	An instance of the MISP platform for publishing and sharing security events. It acts as the repository of threat events received. Its synchronization capabilities are useful to keep instances within a domain synchronized (i.e. from the multiple instantiations of the distributed TMB). What is more, it can be synchronized with external MISP instances, such as those of manufacturers or public CSIRTs/CERTs, so that the database of threats reaches relevant people in the security sector and improves the security of the overall ecosystem. 8 Deployment strategies in the projects with examples of the pilots
2ba1876e0259e748d226a329803049d9	104 160	8.1 Introduction	The ERATOSTHENES and CERTIFY solutions are of interest in many scenarios where heterogeneous IoT devices play a key role. The various technologies and procedures for managing devices' lifecycles in such scenarios have been displayed through piloting activities in several scenarios in both projects. In this clause, this present document provides examples of such scenarios and the deployment strategies in the fields of Intelligent Transport Systems, Smart Health, Industry 4.0 scenarios and next generation Aircraft Systems.
2ba1876e0259e748d226a329803049d9	104 160	8.2 Example 1: Connected Vehicles	The number of connected devices in the automotive industry has grown over the years, and this increase comes along with the evolution of the HW and SW that is integrated into vehicles and infrastructures. Over the last years, the electronic architecture of vehicles has been continuously developed to adapt to the new requirements of the users. Modern vehicles can interact with other connected devices to retrieve information about other vehicles or infrastructures (e.g. vehicles, smart traffic lights, smart speed signs) to make driving more comfortable and advise for the best possible decision while supporting smart-city and smart-connectivity trends. These short-range interactions with other vehicles or infrastructure are not the only benefits those modern vehicles can provide to the users. Also, software updates can be executed remotely, eliminating the need to bring the vehicle to the manufacturer facilities, allowing the improvement of the software installed in the ECUs integrated in the vehicles. However, this progress is also accompanied by concerns of the automotive industry about possible cyber threats and the safety reduction of pedestrians or drivers. This connection can be exploited by cyber criminals to carry out attacks remotely, modifying the vehicle behaviour or hindering its function. The 155 [i.15] and 156 [i.16] UN Regulations are proof of this worry, standardizing cybersecurity, and a software update process that the manufacturers should follow on their products. For this situation, this present document presents a scenario (Pilot 1) for the interaction of the vehicle with the infrastructure devices, where a vehicle will be the victim of attacks. This illustrates the deployment methodology followed in a highly distributed scenario, as well as the way in which the technologies developed during the ERATOSTHENES project can detect bad behaviours in the network, identify the potential malicious actors and finally, be able to deal with a cyber-attack. This scenario takes advantage of the solutions ERATOSTHENES provides in fields such as decentralized identity management and device monitoring. Pilot 1 makes use of Physically Unclonable Functions (PUF) to generate uniquely identifying hardware fingerprints, which are then handled by the SSI agent to manage enrolment and identification. The SSI solution is then used to ensure that participants are authorized to perform actions, such as traffic lights sending updates that affect vehicles' driving decisions. The TMB plays a significant role in the deployment by analysing vehicle behaviour, maintaining a trust database for all vehicles and performing monitoring actions to detect potential threats and attacks. Within the TMB, the CTI Sharing Agent is used to record threat events reported in the network and to share anonymized CTI with CERT/CSIRTs of the automotive industry. MUD files are leveraged to apply security configurations and react against threats through mitigations such as critical software updates developed by manufacturers, with file integrity checks performed to protect against tampering attacks. The DLT acts as a backbone for the trustworthiness and identity data, as it maintains an immutable record of the network/individual device's state, which can then be used to support device recovery. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 30 Vehicles are fitted with an IDAPT to be able to interact with the network, while the infrastructure (smart traffic light) is fitted with Raspberry Pi devices. To support complex and innovative projects, extend testing capabilities, and bridge the gap between them, Applus+ IDIADA has developed a vehicle On-Board Unit (OBU), which can be used independently or integrated into a vehicle's electronic architecture. IDAPT (IDIADA ADAS Platform Tool) is a multi-purpose, flexible prototyping/development tool for Connected and Automated Vehicle (CAV) activities. This tool encompasses several individual CAV components into one single unit with one single power supply, allowing easy installation and removal from a vehicle. Figure 11: Pilot 1 deployment instantiation The first use case is focused on the communication between the vehicle and its exterior devices on the road. This present document considers two types of communications for this case: a) Vehicle-to-Infrastructure (V2I) and b) Vehicle-to-Vehicle (V2V), covering both scenarios that can be carried out in a situation where the vehicles and the infrastructure can be connected to each other. The exact scenario uses a vehicle that communicates through an OBU with a smart traffic light. The vehicle will act according to the inputs that it receives from this infrastructure device. Green Light Optimized Speed Advisory (GLOSA) is an example used in such situations where the vehicle would adapt its speed depending on the state of the cycle the traffic light is in. A second vehicle fitted with an OBU is also present. The aim of this additional vehicle, and the third actor in the scenario, is to send conflicting/malicious messages to the first vehicle, trying to destabilize the previous established communication between the first vehicle and the infrastructure (smart traffic light). The second use case faces one of the most challenging and newest worries of the automotive world, which is the remote software updates. A server is set up to be able to send and receive messages. This packet exchange is done with a vehicle in the test field fitted with an OBU (able to communicate with the server). The intention of this communication is to simulate that one of the ECUs placed in this specific vehicle needs to update its software, and instead of going to the manufacturer's facilities to update it manually, the code will be downloaded from the cloud and installed autonomously.
2ba1876e0259e748d226a329803049d9	104 160	8.3 Example 2: Smart Health	Tellu is an IoT application provider in the eHealth market with an Edge-based SaaS for remote patient monitoring and assistance product. The Tellu Health Gateway, which is deployed in every patient's home, is at the core of the service and is responsible for collecting data from various medical sensors and sending them to the back-end cloud services. The services analyse the data and record them in the patient's electronic health journal. Abnormal situations, such as fell-down and abrupt increase of blood pressure, are notified to the healthcare team. The gateway also hosts logics for pre-processing the raw data, to: (i) limit data exchange between the gateway and the Cloud with the aim of preserving bandwidth; ETSI ETSI TR 104 160 V1.1.1 (2025-10) 31 (ii) increase security and privacy; and (iii) ensure continuity of service even in case of no Internet connection. Driven by the market trends, Tellu is aiming at transforming their product from a closed remote patient monitoring service to an open platform for home assistance, with two major extensions: 1) The healthcare gateways will be able to collect data from not only the standard IoT devices distributed by Tellu, but also the patient's own devices; 2) Third-party developers will be able to provide value-added services on top of the Tellu platform, integrating and utilizing the sensor data and the standard Tellu services in innovative ways. Tellu will transfer to a platform provider and build an ecosystem around its Edge platform. Pilot 2 is focused on the Remote Patient Monitoring system used by Tellu to facilitate remote assistance to follow up on patients suffering from chronic diseases such as diabetes, COPD or Covid-19, allowing patients to stay home during treatment, care, and foster self-care. It includes a Personal Health Gateway, which is deployed in every patient's home that is responsible for collecting data from various medical sensors and sending them to the back-end Cloud services. The services provide data to health personnel, allowing remote patient monitoring. Data is recorded in the patient's electronic health journal and normalized according to standard eHealth ontologies to allow performing various analysis. The objective of the pilot is to demonstrate secure enrolment, identity management, and trust monitoring of critical zero-touch devices. Use Case 1 is aimed at the trusted and secure onboarding of PHGs on the Tellu system. This achievement is realized through the integration of three key technologies developed in the ERATOSTHENES project: Physically Unclonable Function (PUF), Self-Sovereign Identity (SSI), and Distributed Ledger Technology (DLT). Figure 12: Key ERATOSTHENES components in pilot 2 Use case 2 is about the trust management of devices and services and is building on Use Case 1. The main device is the Personal Health Gateway (PHG), which manages a set of medical sensors attached to it. The PHG is responsible for sending the patient's medical data over the gateway to the Tellu backend service. The PHG can be compromised and exploited to send fake data, so the device should be continuously monitored to ensure that data from the gateway can be trusted. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 32 This pilot saw the deployment of the ERATOSTHENES components through a containerized setup on both the Personal Health Gateway (IoT layer) and the cloud server. A Raspberry Pi 3 with a Debian image (version 11) is installed as the gateway - all client-side components are deployed on the Raspberry Pi, together with an MQTT client capable of sending data to the server. The deployment server is launched on an Ubuntu-based Virtual Machine (VM) on AWS.
2ba1876e0259e748d226a329803049d9	104 160	8.4 Example 3: Industry 4.0	Digital Worx (DWG) is a provider for Industry 4.0 solutions with a focus on integration IoT into customized shop floor and productivity systems. DWG provides solutions for retrofitting sensor and cloud interfaces in machining, tracking production assets, and mobile solutions to optimize human workflows in industrial productions. The solutions operate in high security sensitive areas such as industrial automotive production, where connected systems, assets, and communication should be protected from malicious attacks or failures to prevent production downtimes. Thus, process related industry and production have a strong incentive to avoid downtimes. With Industry 4.0 reliability and security of manufacturing in such industry has become more complex. Industry 4.0 offers new opportunities for optimizing production but as well is increasing the attack surface of production systems. Ransomware infiltrated by PC workplaces has become a common threat for production systems. DWG is aiming to increase security by design in industrial IoT network and communication by introducing novel approaches on IoT Asset Identification and the use of disposable IDs to identify trustworthy entities in communication networks. The system should implement a level of trust and resilience in industrial communication networks to prevent, defend and isolate malicious attackers hiding or faking their true identities. Currently, string-based static identifiers are used for IoT asset management and authorization. Identifiers are shared between communication parties in the network, processed and stored in sub-systems of the manufacturing process, operating apps, and vendor databases. The sharing and usage of identifiers cannot be effectively supervised in such complex environments. Thanks to the ERATOSTHENES solution, the PUF-based authentication will allow univocal authentication of devices throughout their lifetime, while the identity framework will enable the use of disposable identities specific for scopes, contexts, and time limits, allowing fine-grained authorization and access control. This will allow operators and devices to carry out the processes required on a shopfloor, like sharing machines' sensor data to perform analysis and maintenance. The strong authentication mechanisms will reduce potential attacks on the system through, e.g. data poisoning, by means of forgeries or impersonations. The identity system will be complemented by reputation and trust management and intrusion detection and protection mechanisms, improving the security of the system to reduce and mitigate cyber-attacks that jeopardize the factory's well-functioning. Figure 13: Key ERATOSTHENES components in pilot 3 Pilot 3 aims to solve and assess identification problems in industrial IoT setups. In the first use case, a PUF-based solution is developed to generate hardware fingerprints for assets. PUF makes use of micro variations that occur during the semiconductor manufacturing process. A service-oriented solution is developed to identify and register assets using secure disposal ID. IDs are created based on state-of-the-art cryptographic algorithms. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 33 In use case 2, a ledger ID is implemented as a distributed service on the industrial edge. The service helps to carry out operations using an Application Programming Interface (API) exposed by an application. The tasks of the service range from generating disposal IDs to store them in a distributed ledger. The ledger facilitates authorized access using Access Control Lists (ACL) managed by a smart contract. Use case 3 concerns itself with trust and permission systems through disposal identifiers. The use case is well suited for an industrial customer who employs several types of IoT devices and wants to create another layer of protection. A disposal ID is multi-faceted, empowered by processes, data, and communication links. Each aspect of a disposal ID is controlled by a smart contract. The trust and permission service API provides a mechanism to exchange information. It regularly checks the validity of the disposal ID and its cryptographic keys. An asset is deregistered in a suspicious event or if it is under attack, by revoking its disposal ID. It ensures that a malicious actor does not affect other assets of a critical network. Use case 4 is about open-sourcing the disposal ID solution. It needs to be integrated with every modern IoT solution in its final form. Therefore, making it open source will encourage IoT developers to adopt and standardize it. Use case 5 employs distributed and decentralized technologies for asset identification. The solution is scalable by design since it incorporates distributed technologies. The overall concept, architecture and application services are tested and approved in an industrial IoT testbed, embedding industrial manufacturing sites. The physical deployment uses a Raspberry Pi Model 4B1 for the client-side deployment, whereas the server-side components are deployed on a private server hosted by DWG on their premise. The server is based on Linux® Container (LXC) technology and maintained by Proxmox. NOTE: Linux® is the registered trademark of Linus Torvalds in the U.S. and other countries.
2ba1876e0259e748d226a329803049d9	104 160	8.5 Example 4: Connected Cabin System	Next-generation aircraft are expected to use many IoT-connected devices supporting new and improved services in the cabin. The shift promises: i) personalized experience for passengers, e.g. through customized In-Flight-Entertainment (IFE); ii) new revenue streams for airlines, such as delivering targeted retail offers; and iii) smarter operations like Prognostics and Health Management (PHM) applications through a detailed view on the evolving status based on the connected sensors. This will lead to a high volume of data GBs up to TBs per second and by the heterogeneity of devices. Devices will be connected through wired (e.g. the Ethernet-based AFDX-ARINC 664, CAN bus, ARINC429) or wireless technologies (e.g. IEEE 802.11 [i.51], ECMA-368 [i.52], IEEE 802.15.3 [i.53]). The heterogeneity is also manifested in the different computational capabilities to host services. Although these cabin systems are classed as non-essential to flight safety, they still fall under aviation airworthiness guidance, certifications and regulations (e.g. from RTCA, EUROCAE [i.41], FAA [i.42] and EASA [i.43]) such as the AC 20-168 [i.17] and the RTCA DO-313 [i.18]. These require verification of the security of the wired and wireless systems preventing any unintended change to the systems during operations. Hardware, software, network traffic, and data all require scrutiny, especially when Commercial Off-The-Shelf (COTS) components are integrated and alternative test methods are needed. All in all, there is a clear need to protect these devices throughout their lifecycle and generate appropriate evidence. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 34 Figure 14: High-level block diagram of the CERTIFY use case for the connected cabin system As shown in Figure 14, CERTIFY use case considers an environment constituted by IoT devices deployed in the connected cabin and infrastructural remote services hosted by the component and system manufacturer, and the airline. In the cabin, the devices will belong to two classes: i) IoT node devices having a small footprint in terms of "Size, Weight, Power and Cost" (low-SWaP-C); and ii) high-end embedded central controller devices able to host more complex software services and manage entire functionalities in the cabin. In the pilot, these devices have been instantiated by a custom RISC-V based node and an off-the-shelf high-end embedded board based on the ARM instruction set, respectively. Additionally, an aircraft gateway oversees the communications to/from the aircraft. This heterogeneous architecture requires a trade-off analysis on the cybersecurity services and functionalities of the CERTIFY framework that can be deployed. The pilot is divided in three different scenarios covering multiple stages of the lifecycle: Scenario 1 - Installation of a new component. A new component needs to be installed in the cabin. This could exemplify the adoption of a new smart component (e.g. a smart coffee machine). The process should be carried out without compromising the cybersecurity posture of the system. Thus, it will include secure bootstrapping, initial update, and customization for the specific deployment environment by considering the security configuration defined by the product owner/manufacturer during evaluation for the original certification. Moreover, if the new component is a replacement for a previously installed one, secure decommissioning, including reset and wipe out of any sensitive data, should be performed by the maintenance operator. Scenario 2 - Operations and monitoring. Data is periodically collected in the cabin with a frequency that is dependent on application and services, e.g. for monitoring, optimization, and preventive maintenance. Additionally, passengers' devices and the usage of a wireless network generate a wider attack surface. External infrastructures may also upload data for onboard connectivity experience and In-Flight Entertainment (IFE) services, and the product owner may also need the availability of a remote connectivity to perform device reconfigurations. An environment that requires such operations demands vulnerability management and anomaly detection throughout the entire operational phase. Scenario 3 - Replacement and repurposing. When a cabin system component fails, a compatible replacement Line-Replaceable Unit (LRU) could be repurposed for the specific target system to minimize downtime. Airline, maintainer, product owner, and maintenance operator are all involved to manage different steps of the process. It is important to check that the device has all the characteristics needed to be repurposed before using it. Indeed, the new deployment may require different capabilities to host services and security features. Therefore, the new usage should be among the ones foreseen and certified by the manufacturer so that proper reconfiguration can be implemented. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 35
2ba1876e0259e748d226a329803049d9	104 160	9 Gap Analysis and Recommendations
2ba1876e0259e748d226a329803049d9	104 160	9.1 Introduction	The rapid growth of the IoT has drastically increased the number of connected devices, bringing significant security and privacy challenges across various industries. As these devices become deeply integrated into critical systems and everyday life, their vulnerabilities can have widespread consequences. To address these risks, the European Union's Cyber Resilience Act (CRA) introduces strict requirements to establish a cybersecurity baseline for IoT products throughout their entire lifecycle. By placing responsibility on manufacturers to secure devices throughout their entire lifecycle, the CRA seeks to ensure that devices are secure by design, fit for purpose, and protected against emerging threats. Additionally, cyber incidents and cyber-threat intelligence should be shared across ecosystems, aiming for a widespread improvement on the security of solutions and the achievement of a collaborative cyber-shield. To achieve this, the CRA sets out to: • Facilitate the secure development of digital products and their components; • Define cybersecurity rules for placing products on the market; • Define requirements for the design, development, and production of products; • Define requirements for the processes for handling vulnerabilities; • Establish rules on market surveillance and enforcement; • Establish different proof of conformity processes (self-declaration, third-party assessment, etc.) depending on the category the products fall in. The CRA's scope and impact on IoT devices makes it truly relevant to ERATOSTHENES and CERTIFY and the contents discussed in the present document. Lifecycle management, threat detection, sharing and mitigation techniques, secure identification, timely security updates, to name a few, are all relevant to the goals of the regulation. In the following, this present document overviews desirable properties from such security standards and regulations that are challenging to achieve and provide recommendations through the solutions developed in the two projects and the experience obtained in the piloting activities. Apart from the mentioned standards and regulations, the contents in this clause are relevant to, and will be related to, several CRA-aligned standards still in development, such as: • ETSI EN 304 632 [i.54], which will provide security requirements and assessment criteria covering elements defined in CRA Annex I for smart home products with security functionalities, including smart door locks, security cameras, baby monitoring systems and alarm systems. • ETSI EN 304 633 [i.55], which will provide security requirements and assessment criteria covering elements defined in CRA Annex I for Internet connected toys covered by Directive 2009/48/EC [i.56] that have social interactive features (e.g. speaking or filming) or that have location tracking features. • ETSI EN 304 634 [i.57], which will provide security requirements and assessment criteria covering elements defined in CRA Annex I for personal wearable products to be worn or placed on a human body that have a health monitoring (such as tracking) purpose and to which Regulation (EU) 2017/745 [i.58] or Regulation (EU) 2017/746 [i.59] do not apply or personal wearable products that are intended for the use by and for children. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 36 9.2 Desirable properties in standards, regulations and best practices
2ba1876e0259e748d226a329803049d9	104 160	9.2.0 Introduction	There exist several desirable properties that are discussed in relevant IoT standards, regulations and best practices documents, and particularly the CRA. Achieving these principles presents challenges derived from the inherent requirements of such properties and the characteristics of IoT environments such as heterogeneity of devices, large numbers of participants or hardware constraints. In this clause, the present document gives an overview of some of these relevant properties, their relationship to standards, and recommendations on how it could be possible to tackle them coming from the solutions of ERATOSTHENES and CERTIFY.
2ba1876e0259e748d226a329803049d9	104 160	9.2.1 Security by Design	Security by design approaches aim to make cybersecurity a primary perspective in the design, development, and production of products, in contrast to the addition of security characteristics at later stages. The CRA aims to apply this notion to products with digital elements. This sentiment is also reflected in multiple requirements established in relevant standards, from basic security requirements for any device to the provisions of risk assessment, secure development or safety features for the products. These are summarized in the following table. Requirements Standards and regulations Basic security requirements CRA, ETSI EN 303 645 [i.19], EUCS [i.21] Securely store sensitive security parameters ETSI EN 303 645 [i.19] (Provision 5.4-1) + RED [i.22] + CRA (I.1-3c I.1-3d), IoT security codes Australia [i.44], ENISA Good practices for IoT devices [i.23] Comprehensive Cybersecurity Risk Assessment CRA (10-2. I.1-3h I.1-3i), CRA (I.1-1) The product should be built with effectively implemented safety features EUCS Facilitate the secure development of products with digital elements and their components CRA To address this, CERTIFY introduces the automation tool CyberPass, which streamlines the conformity assessment process based on ETSI EN 303 645 [i.19]. This standard was highlighted by the CRA Requirements Standards Mapping study conducted by ENISA and the European Commission's Joint Research Centre since it maps to most of the CRA essential requirements. The tool provides a model-based evaluation and certification approach, allowing security to be tested from the early design stages and supporting automation of the conformity assessment process to ensure scalability.
2ba1876e0259e748d226a329803049d9	104 160	9.2.2 Identity Generation and Management	To achieve cybersecurity notions such as confidentiality, integrity and authenticity it is paramount to establish robust identity management mechanisms. The CRA and other IoT security regulations highlight the needs for strong access control mechanisms that ultimately should also be based on authentication and identity management solutions: Requirements Standards and regulations Tamper-Resistant Implementation of Unique Device Identity ETSI EN 303 645 [i.19] (Provision 5.4-2) + RED + PSTI (C3.6) [i.24] Unique device identification NISTIR 8259 [i.26], CRA Identity Validation for Secure Access Authorization RED + CRA (I.1-3b, I.2d) Implement Key management and authentication mechanisms ENISA and IETF good practices for IoT DEVICES [i.23], [i.27], SESIP [i.28] To address this, ERATOSTHENES sets up the device with identity material during the development phase, based on strong root identity material such as Physical Unclonable Functions (PUF). During deployment, the identity of the device is checked, and the identity material for the security domain is generated. The result of this process is the creation of attribute-based identity material that is later used during operation for access control to resources and services, based on attribute-based policies that can be managed in a decentralized way or using traditional PEP/PDP approaches. Apart from the security obtained from the strong PUF root identity, sensitive material (such as keys) is always managed in the Trusted Execution Environment of the device, improving security through isolation. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 37
2ba1876e0259e748d226a329803049d9	104 160	9.2.3 Secure Deployment	The CRA emphasizes the importance of a Secure by Default Configuration, ensuring that products with digital elements are designed to be secure from the moment they are deployed, without requiring users to apply additional security measures. This means manufacturers should provide default settings that prioritize security, minimizing vulnerabilities and reducing the risk of cyber threats. Requirements Standards and regulations Secure by Default Configuration RED + CRA (I.1-3a) Minimize exposed attack surfaces ETSI EN 303 645 [i.19] (Provision 5.6-1) + RED + PSTI (C6.1) Define cybersecurity rules for placing products on the market CRA Make installation and maintenance of devices easy ETSI EN 303 645 [i.19] (Provision 5.12-1) + PSTI (C2.5) To address this challenge, both CERTIFY and ERATOSTHENES on the extended MUD files generated during the design phase and continuously updated by the manufacturer. The MUD file is used to automatically reconfigure the device during deployment, and the enrolment process only finishes after the proper security controls are applied. Additionally, this process is linked to the strong identity management approach, ensuring the security of the MUD profile itself.
2ba1876e0259e748d226a329803049d9	104 160	9.2.4 Vulnerability Handling	Part of the CRA essential requirements insist on processes and not only on products: they call for the vulnerability handling processes put in place by manufacturers to ensure the cybersecurity of products with digital elements during the time the product is expected to be in use. In particular, there should be clear processes and formal policies showing that the manufacturer can immediately take the corrective measures necessary to bring that product with digital elements or the manufacturer's processes into conformity, to withdraw or recall the product, as appropriate. NIS2 Directive [i.1] also promotes cooperation and information exchange among EU Member States to prevent and respond to cybersecurity incidents. Requirements Standards and regulations Implement a means to manage reports of vulnerabilities ETSI EN 303 645 [i.19] Transparent Vulnerability Disclosure Policy ETSI EN 303 645 [i.19] (Provision 5.2-1) + CRA (I.2-5) +PSTI (C4.1) + EUCS + NIS2 (e.g. 18, 26) Timely Response to Disclosed Vulnerabilities ETSI EN 303 645 [i.19] (Provision 5.2-2) + CRA (I.2-2 10-6.) Continuous Monitoring and Remediation of Security Vulnerabilities ETSI EN 303 645 [i.19] (Provision 5.2-3) + CRA (I.2-1 10-4. 10-6. 10-12.) PSTI (C4.2 C4.4 C4.5 C4.6), ENISA baseline requirements for IoT Protecting sensitive data NIS2 (121) To address this challenge, both CERTIFY and ERATOSTHENES apply a multi-technology approach where sharing of cyber-threat information is the cornerstone. Particularly, both projects rely on a privacy-preserving CTI sharing component for the anonymized sharing of security alerts, applying data mining and privacy enhancing technologies (Suppression, Generalization, K-Anonymity) to the sensitive attributes in the alerts. External threat alerts and mitigation strategies can be recovered through the same means as a source of information for the security domain. This process is supported by DLT (instantiated as blockchain), that act as a secure and decentralized source for public information storage and IoT event verification. Lastly, the extended MUD, and particularly the Threat MUDs, are used to share mitigations associated with vulnerabilities, which are applied automatically in the security domains, for instance triggering a software update that patches the vulnerability.
2ba1876e0259e748d226a329803049d9	104 160	9.2.5 Continuous Assessment	Even if a device is certified as secure, new threats and vulnerabilities may still emerge over time, potentially compromising its security and invalidating the certificate. The time required for certification can be reduced if detailed and up-to-date information from the manufacturer is available, allowing for a more efficient recertification process when new vulnerabilities arise. CRA requires organizations to maintain a proactive approach to emerging threats, making it crucial to have verifiable documentation and evidence to support the security of devices throughout their lifecycle. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 38 Requirements Standards and regulations Security Anomaly Examination for Telemetry Data ETSI EN 303 645 [i.19] (Provision 5.10-1) + PSTI (7.6), IoT security codes Australia Continuous Conformity Assessment Procedure CRA (10-7.) Proactive Consideration of Changes in Device Conformity CRA (10-9.) To address this, the CERTIFY methodology includes collection, identification, and decision coupled with its real-time monitoring capabilities (e.g. SIEM-SOAR, IDS, runtime attestation, MUD). Security events are securely stored in the Inventory and Registry component. This allows for the identification and handling of any anomalous behaviour while placing its user in a better spot to comply with cybersecurity regulations. ERATOSTHENES follows a zero-trust architecture where trustworthiness of devices is continuously evaluated and taken into account for security decisions. The process includes real-time monitoring, threat modelling and risk assessment based on digital twins that are updated according to events happening in the domain. This results in the dynamic assessment of devices' conformance to the security profiles specified through MUD files and trustworthiness, which are reflected in the digital twin models and persisted in the DLT in an auditable way.
2ba1876e0259e748d226a329803049d9	104 160	9.2.6 Secure Update	The CRA places significant emphasis on software upgrading to ensure the long-term security of products with digital elements. It mandates that manufacturers provide regular security updates to address vulnerabilities, ensuring that devices remain protected against emerging cyber threats. Updates should be delivered in a timely and reliable manner and installed with minimal user intervention. Requirements Standards and regulations Keep software updated ETSI EN 303 645 [i.19] Ensure software integrity ETSI EN 303 645 [i.19] (Provision 5.3-9 Provision 5.3-10) + RED + CRA (I.2-7) + PSTI (C5.2), ENISA and IETF good practices for IoT [i.23], [i.27] Timely Delivery of Security Updates CRA (I.1-3k I.2-2 I.2-7), PSTI (C5.11), IoT security codes Australia Automated SW updates ETSI EN 303 645 [i.19] (Provision 5.3-4) + RED + CRA (I.1-3k) + PSTI (C5.5), IoT security codes Australia Periodic Security Update Checks ETSI EN 303 645 [i.19] (Provision 5.3-5) + PSTI (C5.5) To address this challenge, both projects provide secure device registration based on credentials created after the pre- provisioning process. Along this process, and throughout the operation of the device, a software update process may be automatically triggered because of the availability of a new version or directly enforced as a mitigation (extended MUD) that involves an upgrade to remove a vulnerability. The process will then consist of the recovery of images from a software repository, their automated deployment through the use of digital twins, and the secure installation, including integrity checks.
2ba1876e0259e748d226a329803049d9	104 160	9.2.7 Repurposing and Decommissioning	As cybersecurity threats evolve, devices may require updates, reconfigurations, or upgrades to maintain security standards. However, some changes might exceed the device's capabilities, such as requiring more storage than available or hardware modifications beyond its design. When a device can no longer meet security requirements, it can either be repurposed for a different use case with lower security demands or decommissioned if no viable reuse is possible. Requirements Standards and regulations Use secure data removal techniques ETSI EN 303 645 [i.19]/ ETSI TS 103 645 [i.29]/ETSI TS 103 701 [i.30] Secure Equipment Disposal and Replacement RED Orderly decommissioning IoTSF Security Assurance Framework [i.31] Make installation and maintenance of devices easy ETSI EN 303 645 [i.19] (Provision 5.12-1) + PSTI (C2.5) For repurposing, CERTIFY ensures that when a device is repurposed, it is securely reconfigured to meet its new environment's security needs through the application of security profiles in the MUD file. For decommissioning, CERTIFY and ERATOSTHENES enforce strict data erasure policies, ensuring that all stored information, including digital certificates, DIDs, and encryption keys, is completely removed. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 39
2ba1876e0259e748d226a329803049d9	104 160	9.3 CRA in ERATOSTHENES and CERTIFY pilots
2ba1876e0259e748d226a329803049d9	104 160	9.3.0 Introduction	Clause 9.3 develops further the applicability of ERATOSTHENES, CERTIFY and their pilots as a reference for the CRA. As the CRA recently came into force and its obligations are still further away in the future, even though the text is stable, many aspects will be delegated to implementing acts. Thus, the analysis presented herein might need to be revised when the details and the actual application of the CRA will occur after a transition period. In addition, this present document is dealing with research projects, and it does not claim to perform any conformance test, nor does it plan to undergo a certification process within the context of this exercise. The complex issue of conformity assessment of such solutions remains a gap in the regulatory context. Thus, this present document discusses here one pilot - and its use cases or scenarios - per project in the context of the CRA to bring a better understanding of their impact being developed in close alignment with the reality of the industry, the law, and its evolution, to facilitate the adherence to such regulatory context. The components, architectures and frameworks developed in ERATOSTHENES and CERTIFY can be a step toward alignment with the CRA and its implementation, and particularly for the core roles covered by lifecycle management and information sharing.
2ba1876e0259e748d226a329803049d9	104 160	9.3.1 ERATOSTHENES illustrative use case	To illustrate the implications of the CRA in the project, this present document uses the Intelligent Transport System pilot as a reference. The CRA is a very horizontal piece of legislation with common cybersecurity requirements for all products, regardless of sector or field of application. Most of the devices involved in the pilot would fall under the CRA scope (e.g. IoT nodes, OBUs and roadside units, gateways, etc.). Indeed, Article 2 of the CRA text [i.3] says that the regulation applies to products with digital elements made available on the market, which includes a direct or indirect logical or physical data connection to a device or network. The CRA aims to embed cybersecurity as a fundamental consideration in the design, development, and production of products with digital components. As emphasized in various policy discussions, its successful implementation would ensure a security-by-design approach for all manufacturers selling products in the EU market. This goal can be achieved by enforcing essential cybersecurity requirements and ensuring that products are free from known vulnerabilities before reaching consumers. The first scenario in the pilot starts with the secure bootstrapping and enrolment of the devices involved in Vehicle-to-Everything (V2X) communication into a security domain. Similar to the essential requirements of the CRA, the certifications and security assets introduced during manufacturing will be key during this process and serve as a root of trust for the process. Additionally, the scenario focuses on the operation and monitoring of such devices in a secure way, leaning on the results of such enrolment. This relates to several pillars and topics within the CRA, but especially on the provisions about lifecycle and vulnerability management. If, for instance, a rogue device injects false traffic control data in aims of performing harmful actions to the connected vehicles, the ERATOSTHENES framework, particularly as part of the TMB's duties, will be able to detect it and inform about it in a privacy-preserving manner through the exchange of CTI. Of course, when a vulnerability is detected, one or more digital products within the systems might no longer be compliant with the CRA or at least be impacted by a "known exploited vulnerability". As the CRA requires market operators to act throughout the product's lifecycle, providing support, updates, or mitigation measures, the automated CTI sharing will be key in starting (and completing) such processes. What is more, the scenario goes a step further, covering the vulnerability handling process. It considers the essential requirement established by the CRA on the vulnerability handling processes put in place by manufacturers to ensure the cybersecurity of products with digital elements during the time the product is expected to be in use. Once a vulnerability is identified, the manufacturer should take immediate action to address the issue. This may involve bringing the product or manufacturing processes into compliance or, if necessary, withdrawing or recalling the affected product. The ERATOSTHENES framework allows for not only the detection and notification of vulnerabilities, but also automated collection and application of mitigation measures, thanks to the application of CTI sharing techniques and the application of the extended MUDs. This enables the identification and handling of any anomalous behaviour while helping security domains comply with cybersecurity regulations. The second scenario involves remote software updates in the automotive sector and is particularly one of the key potential outcomes of a vulnerability handling process. Again, the CRA is explicit in the obligation to support and update digital products, especially in the case of vulnerabilities. The ERATOSTHENES framework provides tools for addressing these processes, and particularly for the management of the lifecycle of the device in a secure manner, taking advantage of secure execution, monitoring, trust, and strong identity management. Particularly, as mentioned above, the usage of the extended MUD file emerges as a key solution for many of the challenges established. Each actor can collaboratively contribute, update, and provide a state of the security of the system. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 40 The application of the MUD file (and its expressiveness extensions along with Threat MUDs as proposed in ERATOSTHENES and detailed in the present document) meets the spirit of many of the regulatory provisions contained in the CRA text. Such a tool would help with the dispatching of newly discovered vulnerabilities as well as their mitigation. The enforcement of the latest MUD file policies would support the creation of evidence of a secure state of the system, providing a basis to build on for notification and reporting purposes. The legislation emphasizes that market operators should systematically document key cybersecurity aspects of products with digital elements, including any known vulnerabilities and relevant information from third parties. They are also required to update the cybersecurity risk assessment of their products as needed. Additionally, the CRA introduces detailed notification and reporting requirements for exploited vulnerabilities and major incidents, featuring new elements such as a Single Reporting Platform and a Single Point of Contact for manufacturers. The extended MUD file further strengthens collaboration among stakeholders, promoting a more cohesive approach to IoT security. These measures align with the need for cooperation among key entities involved in vulnerability management and incident response, such as Computer Security Incident Response Teams (CSIRTs), ENISA, and Single Points of Contact. Ideally, the extended MUD file could also serve as a foundation for conformance documentation, whether self-assessed or verified by a third party.
2ba1876e0259e748d226a329803049d9	104 160	9.3.2 CERTIFY illustrative use case	To illustrate the implications of the CRA in the project, this present document uses the Intelligent Transport System pilot as a reference. In a similar vein to the previous clause, most of the devices involved in the pilot would fall under the CRA scope according to [i.20], Article 2 (e.g. IoT nodes, central controllers, aircraft gateway). The CRA sets an ambitious goal: to embed cybersecurity as a fundamental consideration throughout the design, development, and production of products with digital elements. As emphasized in multiple policy discussions, its effective implementation would establish a security by design approach for all manufacturers placing products on the EU market. This could be achieved by making sure that several basic cybersecurity requirements are respected and that products made available do not have any known vulnerability. In the CERTIFY project, this objective is supported through CyberPass, an automation tool that streamlines conformity assessments based on ETSI EN 303 645 [i.19]. Notably, ETSI EN 303 645 [i.19] was highlighted in the CRA Requirements Standards Mapping study [i.45] by ENISA and the European Commission's Joint Research Centre for mapping closely with most of the CRA's essential requirements. The first scenario addressed here involves the secure bootstrapping and integration of a cabin component into a network. As with the CRA's essential requirements, a baseline set of security measures is pushed to the device to be able to join the network. CERTIFY then issues a certificate attesting to the component's secure state, facilitating further demonstration of regulatory compliance. The second scenario, centred on operations and monitoring, is probably the most well-suited for a CRA pilot as it showcases several pillars and angles of the CRA, particularly regarding lifecycle and vulnerability management. If a rogue device were to inject false data or perform harmful actions inside the cabin, CERTIFY's monitoring plane would detect the anomaly. Once a vulnerability is flagged, any affected digital product might stop being compliant with the CRA, or at least be classified as having a "known exploited vulnerability." Under the CRA, market operators should take action in such cases, providing continuing product support, security updates, or mitigation measures throughout the product's entire lifecycle. Furthermore, this scenario also highlights the CRA's process-oriented requirements, which require manufacturers to maintain robust vulnerability-handling procedures to ensure the cybersecurity of a product during its expected use. Policies and processes should show that manufacturers can act immediately: once a flaw is found, they should either fix the product or their own processes or, if necessary, withdraw or recall the product. The CERTIFY methodology includes collection, identification, and decision, and coupled with its real-time monitoring capabilities (e.g. SIEM-SOAR, IDS, runtime attestation, MUD), allows for the identification and handling of any anomalous behaviour while placing its user in a better spot to comply with cybersecurity regulations. These processes are enhanced through continuous collaboration through the projects' PP-CTI sharing mechanisms. The third scenario focuses on the Line-Replaceable Units (LRUs) and further illustrates the CRA's clear mandate for ongoing support and updates of digital products. A peculiarity of this scenario is the possibility of repurposing a device within the network for a different function than originally intended. The CRA explicitly requires manufacturers and operators to assess not only the intended use of a product with digital elements but also its "foreseeable use and misuse". Repurposing a component within a system is therefore a perfect test-based scenario to assess the emergence of new intended uses. Operators should adopt a risk-based approach to continuously evaluate such changes to ensure they do not introduce harmful or unforeseen consequences. This proactive assessment aligns directly with the CRA's lifecycle and risk management obligations. ETSI ETSI TR 104 160 V1.1.1 (2025-10) 41 Figure 15 represents a visual summary of the link between the use case, the CRA and the CERTIFY project. Figure 15: The CERTIFY cybersecurity lifecycle methodology and framework aligned with recent EU Regulation: the CRA example ETSI ETSI TR 104 160 V1.1.1 (2025-10) 42 History Document history V1.1.1 October 2025 Publication
be84c6a7bf8e9c83db98d9703e663ebd	104 119	1 Scope	The present document provides guidelines and recommendations for documentation schemes that support the continuous and consistent documentation of quality and quality related attributes for AI-enabled systems. This includes an analysis of current documentation schemes and Use case examples. It also defines a process how to document AI-enabled systems.
be84c6a7bf8e9c83db98d9703e663ebd	104 119	2 References
be84c6a7bf8e9c83db98d9703e663ebd	104 119	2.1 Normative references	Normative references are not applicable in the present document.
be84c6a7bf8e9c83db98d9703e663ebd	104 119	2.2 Informative references	References are either specific (identified by date of publication and/or edition number or version number) or non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the referenced document (including any amendments) applies. NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee their long-term validity. The following referenced documents may be useful in implementing an ETSI deliverable or add to the reader's understanding, but are not required for conformance to the present document. [i.1] ISO/IEC TR 24028:2020: "Information technology — Artificial intelligence — Overview of trustworthiness in artificial intelligence". [i.2] Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, i.92i.2 (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828. [i.3] OECD, adopted on 2019-05-22, amended on 2023-11-08: "Recommendation of the Council on Artificial Intelligence". [i.4] ISO/IEC 22989:2022: "Information technology — Artificial intelligence — Artificial intelligence concepts and terminology". [i.5] High-Level Expert Group on Artificial Intelligence (HLEG AI), published 2019-04-08: "Ethics guidelines for trustworthy AI". [i.6] ISO/IEC 25059:2023: "Software engineering — Systems and software Quality Requirements and Evaluation (SQuaRE) — Quality model for AI systems". [i.7] ISO/IEC 25010:2023: "Systems and software engineering — Systems and software Quality Requirements and Evaluation (SQuaRE) — Product quality model". [i.8] ISO/IEC 25019:2023: "Systems and software engineering — Systems and software Quality Requirements and Evaluation (SQuaRE) — Quality-in-use model". [i.9] ISO/IEC TR 5469:2024: "Artificial intelligence — Functional safety and AI systems". [i.10] ISO/IEC 23894:2023: "Information technology — Artificial intelligence — Guidance on risk management". [i.11] ISO/IEC 42001:2023: "Artificial intelligence - Management system". ETSI ETSI TR 104 119 V1.1.1 (2025-09) 8 [i.12] ISO/IEC 27001:2022: "Information security, cybersecurity and privacy protection — Information security management systems — Requirements". [i.13] ISO 31000:2018: "Risk management — Guidelines". [i.14] ISO 9241-210:2019: "Ergonomics of human-system interaction - Part 210: Human-centred design for interactive systems". [i.15] ISO 14971:2019: "Medical devices — Application of risk management to medical devices". [i.16] ISO 13849-1:2023: "Safety of machinery — Safety-related parts of control systems. Part 1: General principles for design". [i.17] ISO 21815-1:2022: "Earth-moving machinery — Collision warning and avoidance. Part 1: General requirements". [i.18] EN ISO 16001:2017 "Earth-moving machinery — Object detection systems and visibility aids — Performance requirements and tests". [i.19] T. Gebru, J. Morgenstern, B. Vecchione, et al.: "Datasheets for datasets", Communications of the ACM, volume 64, issue 12, pp. 86-92. [i.20] J. Giner-Miguelez, A. Gómez, and J. Cabot: "DescribeML: a tool for describing machine learning datasets", MODELS '22 Proceedings of the 25th International Conference on Model Driven Engineering Languages and Systems, pp. 22-26, published 2022-11-09. [i.21] D. Adkins, B. Alsallakh, A. Cheema, et al.: "Method cards for prescriptive machine-learning transparency", CAIN '22 Proceedings of the 1st International Conference on AI Engineering: Software Engineering for AI, pp. 90-100, published 2022-10-17. [i.22] M. Arnold, R. K. E. Bellamy, M. Hind, et al.: "FactSheets: Increasing trust in AI services through supplier's declarations of conformity", IBM Journal of Research and Development, volume 63, issue 4/5, pp. 6:1-13, published 2019-09-18. [i.23] ISO/IEC TR 29119-11:2020: "Software and systems engineering — Software testing — Part 11: Guidelines on the testing of AI-based systems". [i.24] ISO/IEC/IEEE 26514:2022: "Systems and software engineering — Design and development of information for users". [i.25] ETSI EG 204 061: "Human Factors (HF); ETSI Accessibility Strategy; Accessibility of ETSI Deliverables and Improvement of the Development Process of Deliverables". [i.26] EN 301 549 (V3.2.1) (2021-03): "Accessibility requirements for ICT products and services". [i.27] ISO/IEC/IEEE 26511:2018: "Systems and software engineering — Requirements for managers of information for users of systems, software, and services". [i.28] ISO/IEC/IEEE 26512:2018: "Systems and software engineering — Requirements for acquirers and suppliers of information for users". [i.29] ISO/IEC/IEEE 26513:2017: "Systems and software engineering — Requirements for testers and reviewers of information for users". [i.30] ISO/IEC/IEEE 15026-2:2022: "Systems and software engineering — Systems and software assurance — Part 2: Assurance case". [i.31] Center for Democracy & Technology (CDT): "Best Practices in AI Documentation: The Imperative of Evidence from Practice". [i.32] Chmielinski, K. S., Newman, S., Taylor, M., Joseph, J., Thomas, K., Yurkofsky, J., & Qiu, Y. C.: "The dataset nutrition label (2nd gen): Leveraging context to mitigate harms in artificial intelligence", arXiv preprint arXiv:2201.03954. [i.33] Procope C., Cheema A., Adkins D., Alsallakh B., Green N., McReynolds E., Pehl G., Wang E., & Zvyagina P.: "System-Level Transparency of Machine Learning", Technical Report, Meta AI. ETSI ETSI TR 104 119 V1.1.1 (2025-09) 9 [i.34] Hutchinson, B., Smart, A., Hanna, A., Denton, E., Greer, C., Kjartansson, O., & Mitchell, M.: "Towards accountability for machine learning datasets: Practices from software engineering and infrastructure", In Proceedings of the 2021 ACM conference on fairness, accountability, and transparency (pp. 560-575). [i.35] Pushkarna, M., Zaldivar, A., & Kjartansson, O.: "Data cards: Purposeful and transparent dataset documentation for responsible ai", In Proceedings of the 2022 ACM Conference on Fairness, Accountability, and Transparency (pp. 1776-1826). [i.36] L. Derczynski, H. Rose Kirk, V. Balachandran, et al.: "Assessing Language Model Deployment with Risk Cards", v1, published 2023-03-31. [i.37] N. Barman, Y. Reznik, and M. Martini: "Datasheet for Subjective and Objective Quality Assessment Datasets", IEEE, 15th International Conference on Quality of Multimedia Experience (QoMEX) 2023, published 2023-07-18. [i.38] M. P. Sendak, M. Gao, N. Brajer, and S. Balu: "Presenting machine learning model information to clinical end users with model facts labels", npj Digit. Med. 3, 41, published 2020-03-23. [i.39] M. P. Hauer, T. D. Krafft, K. Zweig: "Overview of transparency and inspectability mechanisms to achieve accountability of artificial intelligence systems", Cambridge University Press, published 2023-11-24. [i.40] M. Mitchell, S. Wu, A. Zaldivar, et al.: "Model Cards for Model Reporting", Proceedings of the Conference on Fairness, Accountability, and Transparency, pp. 220-229, published 2019-01-29. [i.41] T. K. Gilbert, N. Lambert, S. Dean, et al.: "Reward Reports for Reinforcement Learning", AIES '23 Proceedings of the 2023 AAAI/ACM Conference on AI, Ethics, and Society, pp. 84-130, published 2023-08-29. [i.42] Zweig, K. A., Wenzelburger, G., & Krafft, T. D.: "On chances and risks of security related algorithmic decision making systems", European Journal for Security Research, 3, pp. 181-203. [i.43] Wirth, R., & Hipp, J.: "CRISP-DM: Towards a standard process model for data mining", In Proceedings of the 4th international conference on the practical applications of knowledge discovery and data mining (Vol. 1, pp. 29-39). [i.44] Angelina McMillan-Major, Emily M. Bender: "A Guide for Creating and Documenting Language Datasets with Data Statements Schema Version 3". [i.45] Angelina McMillan-Major, Salomey Osei, et al.: "Reusable Templates and Guides For Documenting Datasets and Models for Natural Language Processing and Generation: A Case Study of the HuggingFace and GEM Data and Model Cards". [i.46] Diaz, M., Kivlichan, I. D., Rosen, R., Baker, D., Amironesei, R., Prabhakaran, V., & Denton, E. (2022, June): "CrowdWorkSheets: Accounting for individual and collective identities underlying crowdsourced dataset annotation". [i.47] Goel, K., Rajani, N. F., Vig, J., Tan, S., Wu, J., Zheng, S., Xiong, C., Bansal, M., & Ré, C. (2021, January): "Robustness Gym: Unifying the NLP evaluation landscape". [i.48] Raji, I. D., & Yang, J. (2020, January): "ABOUT ML: Annotation and Benchmarking on Understanding and Transparency of Machine Learning Lifecycles". [i.49] Shen, H., Deng, W. H., et al.: "Value Cards: An Educational Toolkit for Teaching Social Impacts of Machine Learning through Deliberation", Proceedings of the 2021 ACM Conference on Fairness, Accountability, and Transparency. [i.50] C. Seifert, S. Scherzinger, et al.: "Towards Generating Consumer Labels for Machine Learning Models", Invited Paper 2019. [i.51] Directive (EU) 2016/2102 of the European Parliament and of the Council of 26 October 2016 on the accessibility of the websites and mobile applications of public sector bodies. ETSI ETSI TR 104 119 V1.1.1 (2025-09) 10 [i.52] Floridi, L., Cowls, J., Beltrametti, M. et al.: "AI4People—An Ethical Framework for a Good AI Society: Opportunities, Risks, Principles, and Recommendations", Minds & Machines 28, pp. 689-707 (2018). [i.53] Adewole Adamson and Avery Smith: "Machine Learning and Health Care Disparities in Dermatology". JAMA Dermatology 154 (08/2018). [i.54] S. Alder: "AI Company Exposed 2.5 Million Patient Records Over the Internet". HIPPA Journal (2020). [i.55] Anmol Arora: "Conceptualising Artificial Intelligence as a Digital Healthcare Innovation: An Introductory Review". Medical Devices: Evidence and Research Volume 13 (08/2020), pp. 223-230. [i.56] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. [i.57] K. Ferryman and M. Pitcan: "Fairness in precision medicine". Data & Society, 2018. [i.58] S. D. Fihn, S. Saria, E. Mendonça, S. Hain, M. Matheny, N. Shah, H. Liu, and A. Auerbach: "Deploying AI in clinical settings". In Artificial intelligence in health care: The hope, the hype, the promise, the peril, Matheny M, Israni ST, Ahmed M, and Whicher D (Eds.). National Academy of Medicine, Washington, DC, 2019. [i.59] U.S. Food and Drug Administration (FDA): "Proposed Regulatory Framework for Modifications to Artificial Intelligence / Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)", 2019. [i.60] Sara Gerke, Timo Minssen, and Glenn Cohen: "Ethical and legal challenges of artificial intelligence-driven healthcare", 2020, pp. 295-336. [i.61] M. Ghassemi: "Exploring Healthy Models in ML for Health. AI for Healthcare Equity Conference", AI & Health at MIT, 2021. [i.62] WHO TEAM: Health Ethics & Governance: "Ethics and governance of artificial intelligence for health: WHO guidance". Geneva: World Health Organization (WHO), 2021. [i.63] Lucy Hocking, Sarah Parks, Marlene Altenhofer, and Salil Gunashekar: "Reuse of health data by the European pharmaceutical industry: Current practice and implications for the future", 2019. [i.64] Kelly M. Hoffman, Sophie Trawalter, Jordan R. Axt, and M. Norman Oliver: "Racial bias in pain assessment and treatment recommendations, and false beliefs about biological differences between blacks and whites". Proceedings of the National Academy of Sciences 113, 16 (2016), pp. 4296-4301, 2016. [i.65] Bert-Jaap Koops: "The concept of function creep". Law, Innovation and Technology 13, 1 (2021), pp. 29-56, 2021. [i.66] Zachary Chase Lipton: "The Doctor Just Won't Accept That!", arXiv: Machine Learning (2017). [i.67] Alex McKeown, Miranda Mourby, Paul Harrison, Sophie Walker, Mark Sheehan, and Ilina Singh: "Ethical Issues in Consent for the Reuse of Data in Health Data Platforms". Science and Engineering Ethics 27 (02/2021). [i.68] Marçal Mora-Cantallops, Salvador Sánchez-Alonso, Elena García-Barriocanal, and Miguel-Angel Sicilia: "Traceability for Trustworthy AI: A Review of Models and Tools". Big Data and Cognitive Computing 5, 2 (2021). [i.69] Myura Nagendran, Yang Chen, Christopher A Lovejoy, Anthony C Gordon, Matthieu Komorowski, Hugh Harvey, Eric J Topol, John P A Ioannidis, Gary S Collins, and Mahiben Maruthappu: "Artificial intelligence versus clinicians: systematic review of design, reporting standards, and claims of deep learning studies". BMJ 368 (03/2020), m689. [i.70] BBC News (2017): "Google DeepMind NHS app test broke UK privacy law". ETSI ETSI TR 104 119 V1.1.1 (2025-09) 11 [i.71] J. Brian Pickering: "Trust, but Verify: Informed Consent, AI Technologies, and Public Health Emergencies". Future Internet 13 (2021), p. 132. [i.72] Thomas Ploug and Soren Holm.: "Meta Consent - A Flexible Solution to the Problem of Secondary Use of Health Data". Bioethics 30, 9 (2016), pp. 721-732. [i.73] Inioluwa Deborah Raji, Andrew Smart, Rebecca N. White, Margaret Mitchell, Timnit Gebru, Ben Hutchinson, Jamila Smith-Loud, Daniel Theron, and Parker Barnes: "Closing the AI Accountability Gap: Defining an End-to-End Framework for Internal Algorithmic Auditing", 2020. [i.74] Andrew D. Selbst and Julia E. Powles: "Meaningful Information" and the Right to Explanation. In FAT, 2017. [i.75] Ameneh Shamekhi, Ha Trinh, Timothy W. Bickmore, Tamara R. DeAngelis, Theresa Ellis, Bethlyn V. Houlihan, and Nancy K. Latham: "A Virtual Self-Care Coach for Individuals with Spinal Cord Injury". In Proceedings of the 18th International ACM SIGACCESS Conference on Computers and Accessibility (Reno, Nevada, USA) (ASSETS '16). Association for Computing Machinery, New York, NY, USA, pp. 327-328. [i.76] Helen Smith: "Clinical AI: opacity, accountability, responsibility and liability". AI & SOCIETY 36 (06/2021). [i.77] Darshali Vyas, Leo Eisenstein, and David Jones: "Hidden in Plain Sight — Reconsidering the Use of Race Correction in Clinical Algorithms". New England Journal of Medicine 383 (06 2020). [i.78] Blay Whitby: "Automating Medicine the Ethical Way", 2015. [i.79] Guang Yang, Qinghao Ye, and Jun Xia: "Unbox the Black-box for the Medical Explainable AI via Multi-modal and Multi-centre Data Fusion: A Mini-Review", Two Showcases and Beyond, 2021. [i.80] Robert Challen, Joshua Denny, Martin Pitt, Luke Gompels, Tom Edwards, and Krasimira Tsaneva-Atanasova: "Artificial intelligence, bias and clinical safety". BMJ Quality & Safety 28 (01/2019), bmjqs-2018. [i.81] Samer Ellahham, Nour Ellahham, and Mecit Can Emre Simsekler: "Application of Artificial Intelligence in the Health Care Safety Context: Opportunities and Challenges". American Journal of Medical Quality 35, 4 (2020), pp. 341-348. [i.82] Ravi Manne and Sneha Kantheti: "Application of Artificial Intelligence in Healthcare: Chances and Challenges". Current Journal of Applied Science and Technology 40 (05/2021), pp. 78-89. [i.83] Jessica Morley and Luciano Floridi: "An Ethically Mindful Approach to AI for Health Care". The Lancet 395 (01/2020), pp. 254-255. [i.84] Díaz-Rodríguez, N., Del Ser, J., Coeckelbergh, M., López de Prado, M., Herrera-Viedma, E., & Herrera, F. (2023): "Connecting the dots in trustworthy Artificial Intelligence: From AI principles, ethics, and key requirements to responsible AI systems and regulation". [i.85] Article 22 EU GDPR: "Automated individual decision-making, including profiling". [i.86] "FUTURE-AI: international consensus guideline for trustworthy and deployable artificial intelligence in healthcare". [i.87] Annemarie Hamlin, Chris Rubio, Michele DeSilva: "Technical Writing". [i.88] Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC. [i.89] ISO/IEC AWI 42102: "Information technology — Artificial intelligence — Taxonomy of AI system methods and capabilities" [Draft]. Retrieved June 20, 2025. [i.90] Schmid, T. (2023): "A Systematic and Efficient Approach to the Design of Modular Hybrid AI Systems". In AAAI Spring Symposium: MAKE. ETSI ETSI TR 104 119 V1.1.1 (2025-09) 12 [i.91] Holoyad, T., Schmid, T., & Hildesheim, W.: "Managing and understanding artificial intelligence: From classical to generative AI - A practice guide for decision‑makers, developers and regulators in the age of the EU AI Act". Springer.
be84c6a7bf8e9c83db98d9703e663ebd	104 119	3 Definition of terms, symbols and abbreviations
be84c6a7bf8e9c83db98d9703e663ebd	104 119	3.1 Terms	For the purposes of the present document, the following terms apply: affected person: individuals with limited technical knowledge who may be impacted by AI systems NOTE: They require protection from arbitrary decisions and risks, and may need to take legal measures if they feel unfairly treated. They can be represented by NGOs who possess greater capacities, knowledge, and power. See also: AI subject. AI customer: organization or entity that uses an AI product or service either directly or by its provision to AI users NOTE: Aligned with ISO/IEC 22989 [i.4]: AI customer. AI partner: organization or entity that provides services in the context of AI NOTE 1: AI partners can perform technical development of AI products or services, conduct testing and validation of AI products and services, audit AI usage, evaluate AI products or services and perform other tasks. NOTE 2: This includes roles like AI system integrators, who incorporate AI components into broader systems, data providers, AI evaluators, and AI auditors. NOTE 3: Aligned with ISO/IEC 22989 [i.4]: AI partner. AI producer: organization or entity that designs, develops, tests and deploys products or services that use one or more AI system NOTE 1: This includes AI developers, who focus on creating AI models, implementing computational processes, and verifying both the computation and model performance. NOTE 2: According to the EU AI Act [i.2] an AI producer is also included in the term Deployer, as "a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activity". NOTE 3: Aligned with ISO/IEC 22989 [i.4]: AI producer. AI provider: organization or entity that offers products or services utilizing one or more AI systems NOTE 1: AI providers include AI platform providers, who enable other stakeholders to produce AI services or products, and AI service or product providers, who deliver AI solutions directly to customers. NOTE 2: The EU AI Act [i.2] defines Provider as "a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge". NOTE 3: Aligned with ISO/IEC 22989 [i.4]: AI provider. AI subject: organization or entity that is impacted by an AI system, service or product NOTE 1: This can also include individuals or communities affected by AI applications, such as users of social networks or drivers of AI-automated vehicles. NOTE 2: The EU AI Act [i.2] uses the term affected person equivalently. NOTE 3: Aligned with ISO/IEC 22989 [i.4]: AI subject. ETSI ETSI TR 104 119 V1.1.1 (2025-09) 13 AI user: organization or entity that uses AI products or services NOTE 1: AI user is a sub-role of AI customer. NOTE 2: Aligned with ISO/IEC 22989 [i.4]: AI users. auditor: professionals with deep technical knowledge and understanding of standards and regulations NOTE 1: They identify compliance issues and ensure AI systems meet ethical and operational benchmarks, facilitating successful certification and deployment. NOTE 2: Aligned with ISO/IEC 22989 [i.4]: AI auditor. bias: systematic difference in treatment of certain objects, people, or groups in comparison to others NOTE: Aligned with ISO/IEC 22989 [i.4]: bias. deployer: entities utilizing AI-based products provided by others, requiring sufficient information to effectively incorporate these systems into their own products or services NOTE: The EU AI Act [i.2] uses the term 'deployer' as "a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activity". See also: AI producer. document stakeholder: individual, group, or organization that can affect, be affected by or perceive itself to be affected by the document NOTE: Aligned with ISO/IEC 22989 [i.4]: stakeholder. documentation approach: strategy or plan to create or maintain a document by well structured decisions and activities which base on fundamental goals documentation item: subject of a documentation artifact NOTE: The subject of a documentation (i.e. the documentation item) can be e.g. a software component, AI model, AI-enabled systems, training data, processes, or organizational structures. documentation scheme: framework of methods, tools and templates that realizes a documentation approach NOTE: Documentation schemes are often supported by successful empiric evidence. documentation technique: specific format, structure and modality of how information is presented by a document NOTE: Documentation techniques are chosen to most effectively address the intended audience (recipients of the information to be transported) of a document. provider (documentation): entities responsible for documenting the technical details of AI products, from requirements to test results, ensuring high-quality and trustworthy AI systems regulator: organizations and entities that have the authority to set, implement and enforce the legal requirements as intended in policies set forth by policy makers NOTE 1: Those entities are e.g. governmental organizations or bodies like the European Unio. They are responsible for setting guidelines and standards to ensure the ethical development and deployment of AI systems. They focus e.g. on transparency, accountability, and fairness, and assess the applicability and effects of current regulations in AI. NOTE 2: Aligned with ISO/IEC 22989 [i.4]: regulators. relevant authorities: organizations or entities that can have an impact on an AI system, service or product NOTE 1: This includes policy makers and regulators. NOTE 2: Aligned with ISO/IEC 22989 [i.4]: relevant authorities. ETSI ETSI TR 104 119 V1.1.1 (2025-09) 14 trust: individual stakeholders confidence that an entity, organization or individual behaves or reacts as expected by the individual NOTE: Subjective factors influence a person's trust in a system, including personal experiences, beliefs, needs, emotional and rational thinking based on the perceived information on an AI system's impact. Mostly the system behaviour expected by a person includes the absence of negative consequences to itself. trustworthiness: ability to meet stakeholder expectations in a verifiable way NOTE: Aligned with ISO/IEC 22989 [i.4]: trustworthiness.
be84c6a7bf8e9c83db98d9703e663ebd	104 119	3.2 Symbols	Void.
be84c6a7bf8e9c83db98d9703e663ebd	104 119	3.3 Abbreviations	For the purposes of the present document, the following abbreviations apply: CE Conformité Européenne (European Conformity) CRISP-DM CRoss-Industry Standard Process for Data Mining DSL Domain-Specific Language GDPR General Data Protection Regulation GPAI General-Purpose AI (System) HIPAA Health Insurance Portability and Accountability Act HLEG High-Level Expert Group on Artificial Intelligence KPI Key Performance Indicator LLM Large Language Model NLP Natural Language Processing NLU Natural Language Understanding QoE Quality of Experience SMEs Small and Medium Enterprises
be84c6a7bf8e9c83db98d9703e663ebd	104 119	4 Purpose of Documentation	The motivation to create effective documentation for AI-enabled systems became very high, since those systems are used so widely and regulation has been set up to limit potential risks that may arise from those system developed and put on the market with inappropriate characteristics. One goal of mitigating those risks is to gain trust of involved and affected persons by such AI-enabled systems. Trust and trustworthiness The deeper technical systems take effect on human life, the stronger the needs of humans are to trust those systems. The term trust, however, is not an objective characteristic of an entity all humans can believe in but rather a statement of an individual person who trusts the entity. Typically, one can trust a manifold of entities, such as other persons, groups of persons, organizations, technical systems, processes and so on. Trust itself can be described as the expectation of a person into an entity that it will behave "as expected" without having negative consequences on this person. While the term trust can be seen as a statement of an individual person or stakeholder, trustworthiness is a characteristic of the entity, e.g. defined by ISO/IEC 22989 [i.4] as the "ability to meet stakeholders' expectations in a verifiable way". However, verifying trustworthiness cannot easily be measured objectively, as the corresponding stakeholder's expectations may depends on individuals. Thus, the term trustworthiness can only be verified, when it is broken down into a set of characteristics that can be measured more objectively. Currently, there exist several proposals of how trustworthiness can be supported. Annex B lists and discusses these definitions. But even if all the broken-down characteristics have been assessed, trust can only arise in a stakeholder's mind, if the stakeholder is actually aware of all these characteristics and information. Thus, it is important to have appropriate means, i.e. documentations, to provide this information. ETSI ETSI TR 104 119 V1.1.1 (2025-09) 15 From regulatory perspective, the basis for trustworthiness is formed by legal requirements. The European AI Act requires, along with other standardization documents, compliance with quality characteristics such as transparency, accuracy, robustness, and fairness, as well as compliance with legal obligations to protect fundamental rights such as privacy, non-discrimination, and human control. In practice, however, trust in AI systems is influenced by numerous factors that go beyond regulatory compliance. In this context, humans develop trust based on their previous experiences with AI, their personal beliefs and needs, and how well certain effects of the system match their expectations. The perception of trust is shaped by individual factors, such as the user's understanding of how the AI system works, their interaction with the system and their general attitude towards the technology. A catalyst is therefore needed to bridge the gap between the definition of trustworthiness in the AI law and the actual trust perceived by users. This catalyst is based on transparency in a decisive manner, enabling clarity to make AI systems assessable to demonstrate the system's alignment with the human dimensions of trust. To create a trustworthy AI systems, humans trust in, it is essential to consider both the formal requirements as well as the human dimension of trust. Purposes of documenting AI based systems AI documentation serves multiple critical purposes, each tailored to different stakeholders and regulatory environments. At its core, documentation is essential for ensuring transparency, accountability, and trustworthiness in AI systems, a deeper analysis of the risks associated with a not well documented AI systems is reported in Annex C. AI documentation can vary widely, from fulfilling regulatory requirements to providing insights into the technical foundations of the system, depending on its intended audience and purpose: • Compliance with regulation and standards. One of the primary reasons for AI documentation is to comply with regulatory standards. Governments and industry bodies impose strict guidelines to ensure AI systems operate fairly, safely, and without undue bias. Proper documentation helps organizations demonstrate compliance with laws such as the EU AI Act and GDPR. It details how data is handled, how models are tested for bias and fairness, and how decisions made by AI systems align with ethical and legal standards. By maintaining comprehensive records, organizations can navigate audits more effectively and mitigate legal risks. • Information source for benchmarking. Beyond regulatory compliance, AI documentation also plays a crucial role in benchmarking. AI systems are often evaluated based on their accuracy, robustness, and efficiency. Benchmarking documentation provides details on the datasets used for evaluation, the methodologies employed, and comparative results against industry standards or previous models. This transparency allows researchers and developers to assess the strengths and weaknesses of an AI model, ensuring continuous improvement and fostering innovation. • Data transparency. Another key aspect of AI documentation is providing insight into the data sources used for training and testing. Data is the foundation of any AI system, and understanding its origins, composition, and potential biases is vital. Documentation should describe how datasets were collected, cleaned, and processed. It should highlight any limitations or biases inherent in the data and outline steps taken to mitigate these issues. This level of transparency helps users and regulators assess the reliability and fairness of the AI system. • System design and development process transparency. The development process and internal architecture of an AI system also require thorough documentation. This includes explanations of model design choices, training procedures, hyperparameter tuning, and algorithmic modifications. For engineers and researchers, such documentation serves as a roadmap, facilitating collaboration, debugging, and future iterations. Understanding how an AI system was built and the reasoning behind its design choices allows teams to refine their approaches and improve performance over time. All these documentation efforts contribute to the broader goal of increasing trust in AI systems. Whether it's regulators ensuring compliance, researchers benchmarking performance, or end-users seeking reassurance about fairness and reliability, well-documented AI systems foster confidence. Transparency in data, design, and decision-making processes reassures stakeholders that the AI operates as intended and aligns with ethical and legal expectations. AI documentation is not just an administrative requirement, it is a fundamental pillar of responsible AI development. It bridges the gap between technical innovation and public trust, ensuring that AI systems are not only effective but also accountable, fair, and reliable. ETSI ETSI TR 104 119 V1.1.1 (2025-09) 16
be84c6a7bf8e9c83db98d9703e663ebd	104 119	5 Motivation for a Harmonized Documentation Scheme
be84c6a7bf8e9c83db98d9703e663ebd	104 119	5.1 Current AI Documentation Schemes	In the field of AI documentation, several approaches have been developed to support transparency, ethics, quality, reproducibility, discoverability, trust and accountability throughout the various stages of data and AI model life cycles. The present clause gives an overview of existing works grouped by the focus the documentation schemes available in the literature. Details are provided in Annex D giving information of what they document, the intended audience for the documentation, the stage of the development life cycle at which the documentation is created and the techniques employed for documenting. Also, their respective strengths, weaknesses, and existing gaps in the context of the EU AI Act are highlighted. The approaches are grouped into: • Data-focused documentation approaches (see clause D.1) which primarily concentrate on the documentation of the datasets used in training, validation and test of AI systems or models. Approaches include strategies to document the creation and use of datasets [i.19], to document the structure, data provenance and social concerns of ML datasets [i.20], to enhance data quality standards by providing a clear and standardized way to describe datasets [i.32], to promote transparency and responsibility in AI dataset usage [i.35], and, to improve accountability in Machine Learning (ML) datasets [i.34]. • Model-and-method-focused documentation approaches (see clause D.2) that primarily focus on documenting ML models and methods used within AI systems. Approaches include strategies for documenting the characteristics of trained models, including their performance, intended use cases, and any relevant attributes for which performance may vary [i.40]. Others focus on supporting the robust auditing and evaluation of ML systems through the documentation of both ML models and non-ML components like data acquisition and human-in-the-loop interfaces [i.21]. • System-focused documentation approaches (see clause D.3) that focus on documenting the entirety of an AI system, including datasets, models and methods, APIs, and non-AI/ML components that interact as part of the overall AI system. Available solutions offer a broader perspective by providing documentation coverage for both, models and datasets [i.22], and documenting and communicating various aspects of ML systems, including data, models, and decision-making processes [i.33]. The aim of these strategies is to enhance user trust and understanding by providing clear and accessible information about how ML systems work and their potential impacts. • Domain specific documentation approaches (see clause D.4) which primarily target the documentation of datasets, models, methods, and AI systems within a specific domain. Approaches provide strategies to ensure that critical model information is accurately conveyed to the end-users in the healthcare domain [i.38], to focus on structure assessment and the documentation of risks associated with language model applications [i.36], and, to document the Quality of Experience (QoE) of users [i.37].
be84c6a7bf8e9c83db98d9703e663ebd	104 119	5.2 Gaps to EU AI Act Requirements	The analysis in clause D.5 demonstrates that while current state-of-the-art AI documentation approaches generally fulfil many of the data-related documentation requirements outlined in the EU AI Act, significant gaps remain. For instance, while Data Cards, DescribeML, Factsheets, and the Dataset Development Life Cycle Documentation Framework provide the most comprehensive coverage of data-related requirements, they often overlook key elements. Specifically, validation procedures and impact assessments (which are critical when personal data is involved) are insufficiently documented. These components are essential to ensure transparency around how data has been validated for accuracy and fairness, and to understand the potential privacy implications of AI systems. Out of the evaluated approaches, only five sufficiently address these crucial data validation and impact assessment requirements, leaving a considerable gap in compliance with the EU AI Act. ETSI ETSI TR 104 119 V1.1.1 (2025-09) 17 Furthermore, a more pronounced shortcoming arises in the documentation of AI system-related requirements mandated by the EU AI Act. These requirements include documenting technical specifications, operational constraints, and system-level risk assessments, which are vital for ensuring the safe and responsible deployment of AI systems. While Factsheets, System Cards, and Model Facts Labels attempt to address most of these system-level needs, the remaining approaches offer minimal coverage. This lack of documentation for system-related aspects severely limits stakeholders' ability to assess the overall safety, performance, and accountability of AI systems. These gaps suggest that existing documentation approaches are predominantly data-centric and fail to provide a comprehensive view of the AI system as a whole, which is crucial for regulatory compliance and trustworthiness. A similar shortcoming is evident when it comes to control-related documentation requirements. These controls include processes for continuous monitoring, human oversight mechanisms, and safeguards for mitigating risks during operation. The majority of the reviewed AI documentation approaches (see Annex D) either do not address control- related elements or do so only superficially. This omission poses a serious challenge, as these controls are necessary to ensure that AI systems remain compliant throughout their life cycle, particularly in high-risk applications. Without robust documentation on control mechanisms, it becomes difficult to ensure ongoing compliance, manage risks, and facilitate accountability as required by the EU AI Act. The Assurance Case framework [i.30] (see Annex D) is theoretically suitable to address any documentation requirements, by demanding the respective evidences by any means necessary. Thereby, the provision of evidences relies on any other suitable documentation approaches. Additionally, the argumentation that states why the sub-claims sufficiently imply the main-claim may be highly subjective. These shortcomings highlight a critical issue: existing AI documentation approaches are fragmented and lack consistency in addressing the full spectrum of requirements outlined in the EU AI Act. While certain approaches focus heavily on data transparency, they fall short in areas related to system architecture, performance monitoring, and control mechanisms, which are equally important for ensuring that AI systems are safe, transparent, and ethical. The fragmented nature of these approaches points to the urgent need for a more holistic and integrated documentation framework. A unified approach would ensure comprehensive coverage of the Act's requirements, addressing not just the data-related aspects but also the system-level specifications, operational constraints, and control mechanisms necessary for regulatory compliance. Such a framework would enable developers, regulators, and users alike to have a clear, consistent, and complete understanding of AI systems, thus improving transparency, accountability, and trust in AI technologies.
be84c6a7bf8e9c83db98d9703e663ebd	104 119	5.3 Summary	Based on the inconsistencies and gaps identified, the development a unified AI documentation scheme is needed that ensures thorough coverage of all documentation requirements mandated by the EU AI Act. Such a unified scheme would streamline documentation processes, provide clarity, and facilitate compliance, ultimately fostering a safer and more accountable AI ecosystem. Taking the European single market as an example - proceeding from the current standardization landscape, operators seeking access to the European single market with AI-related products and services can encounter documentation shortcomings related to conformity assessment. Such shortcomings reflect a lack of guidance on how to properly declare conformity to fulfil the essential requirements for entering a market, e.g. the European single market. Such guidance is of decisive importance for ensuring consistency in fulfilling legislative obligations. For instance, in Europe, the fulfilment of such obligations results in the CE marking as the demonstration of the fulfilment of essential requirements from European legislations. Moreover, for AI systems, documentation is frequently lacking in life cycle-related information, such as updates, modifications, and performance monitoring, which are essential for market surveillance authorities. Especially the insufficient and inconsistent tracking of AI-related quality criteria makes it difficult to assess conformity before as well as after-market access. This provides uncertainty to operators heading to enter a market as well as the authorities' ability to perform thorough inspections and enforce legislative obligations. ETSI ETSI TR 104 119 V1.1.1 (2025-09) 18

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