Article 26: Obligations of Deployers of High-Risk AI Systems
Official Statutory Text
Article 26 Obligations of deployers of high-risk AI systems 1. Deployers of high-risk AI systems shall take appropriate technical and organisational measures to ensure they use such systems in accordance with the instructions for use accompanying the systems, pursuant to paragraphs 3 and 6. 2. Deployers shall assign human oversight to natural persons who have the necessary compet ence, training andauthority , as well as the necessary suppor t. 3. The obligations setout in paragraphs 1 and 2, are without prejudice to other deployer obligations under Uni on or national law and to the deployer ’s freedom to organise its own resources andactivities for the purpose of implementing the human oversight measures indicated by the provider . 4. Without prejudice to paragraphs 1 and 2, to the extent the deployer exercises control over the input data, that deployer shall ensure that in put data is relevant and sufficiently representative in view of the intended purpose of the high-risk AI system. 5. Deployers shall monitor the operation of the high-risk AI system on the basis of the instructions for use and, where relevant, inform providers in accordance with Article 72. Where deployers have reason to consider that the use of the high-risk AI system in accordance with the instructions may result in that AI system presenting arisk within the meaning of Article 79(1), they shall, without undue delay , inform the provider or distributor and the relevant market surveillance authority , and shall suspend the use of that system. Where deployers have identifieda serious incident, they shall also immediately inform first the provider , and then the importer or distributor and the relevant market surveillance authorities of that incident. If the deployer is not able to reach the provider , Article 73 shall apply mutatis mutandis. This obligation shall not cover sensitive operational data of deployers of AI systems which are law enforcement authorities. For deployers that are financial institutions subject to requirements regard ing their internal gover nance, arrangements or processes under Union financial services law , the monitoring obligation setout in the first subparagraph shall be deemed to be fulfilled by complying with the rules on internal governance arrangements, processes and mechanisms pursuant to the relevant financial service law . 6. Deployers of high-risk AI systems shall keep the logs automatically generated by that high-risk AI system to the extent such logs are under their control, for a periodappropriate to the intended purpose of the high-risk AI system, of at least six months, unless provided other wise in applicable Uni on or national law , in particular in Union law on the protect ion of personal data. Deployers that are financial institutions subject to requirements regard ing their internal governance, arrangements or processes under Uni on financial services law shall maintain the logs as par tof the documentation kept pursuant to the relevant Uni on financial service law . 7. Before putting into service or using a high-risk AI system at the wo rkplace, deployers who are employers shall inform wo rkers’ representatives and the affected workers that they will be subject to the use of the high-risk AI system. This information shall be provided, where applicable, in accordance with the rules and procedures laid down in Union and national law and practice on information of workers and their representatives. 8. Deployers of high-risk AI systems that are public authorities, or Uni on institutions, bodies, offices or agencies shall comply with the registration obligations referred to in Article 49. When such deployers find that the high-risk AI system that they envisage using has not been registered in the EU database refer red to in Article 71, they shall not use that system and shall inform the provider or the distributor . 9. Where applicable, deployers of high-risk AI systems shall use the information provided under Article 13 of this Regulation to comply with their obligation to carry out a data protection impact assessment under Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680. 10. Without prejudice to Directive (EU) 2016/680, in the framework of an investigation for the targeted search of a person suspected or convicted of having committeda criminal offe nce, the deployer of a high-risk AI system for post-remote biometric identification shall request an authorisation, ex ante, or without undue delay and no later than 48 hours, by a judicial authority or an administrative authority whose decision is binding and subject to judicial review , for the use of that system, except when it is used for the initial identification of a potential suspect based on objective and verifiable facts directly linked to the offe nce. Each use shall be limited to what is strictly necessary for the investigation of a specific criminal offence. If the authorisation requested pursuant to the first subparagraph is rejected, the use of the post-remote biometric identification system linked to that requestedauthorisation shall be stopped with immediate effect and the personal data linked to the use of the high-risk AI system for which the authorisation was requested shall be deleted. In no case shall such high-risk AI system for post-remote biometric identification be used for law enforcement purposes in an untarget ed way , without any link to a criminal offe nce, a criminal proceeding, agenuine and presentor genuine and foreseeable threatof a criminal offenc e, or the search for a specific missing person. It shall be ensured that no decision that produces an adverse legal effecton a person maybe taken by the law enforcement authorities based solely on the outputof such post-remote biometric identification systems. This paragraph is without prejudice to Article 9 of Regulation (EU) 2016/679 and Article 10 of Directive (EU) 2016/680 for the processing of biometric data. Regardless of the purpose or deployer , each use of such high-risk AI systems shall be documented in the relevant police file and shall be made available to the relevant market surveillance authority and the national data protection authority upon request, excluding the disclosure of sensitive operational datarelated to law enforcement. This subparagraph shall be without prejudice to the powers conferred by Directive (EU) 2016/680 on supervisory authorities. Deployers shall submit annual reports to the relevant market surveillance and national data protection authorities on their use of post-remote biometric identification systems, excluding the disclosure of sensitive operational datarelated to law enforcement. The reports maybe aggregated to cover more than one deplo yment. Member States may introduce, in accordance with Uni on law , more restrictive laws on the use of post-remote biometric identification systems. 11. Without prejudice to Article 50 of this Regulation, deployers of high-risk AI systems referred to in Annex III that make decisions or assist in making decisions related to natural persons shall inform the natural persons that theyare subject to the use of the high-risk AI system. For high-risk AI systems used for law enforcement purposes Article 13 of Directive (EU) 2016/680 shall apply . 12. Deployers shall cooperate with the relevant competent authorities in any action those authorities take in relation to the high-risk AI system in order to implement this Regulation.
European Parliament & Council (Regulation 2024/1689)
View Official EUR-Lex Publication- Take appropriate technical and organisational measures to use high-risk AI systems in accordance with their instructions for use.
- Assign human oversight to natural persons with necessary competence, training, authority, and support.
- If you exercise control over input data, ensure it is relevant and sufficiently representative for the intended purpose of the high-risk AI system.
- Monitor the operation of the high-risk AI system based on instructions for use. Where relevant, inform providers in accordance with Article 72.
- If you have reason to consider that using the system according to instructions may lead to a risk (Art. 79(1)), promptly inform the provider or distributor and the relevant market surveillance authority, and suspend the use of the system.
- Immediately inform the provider (then importer or distributor) and relevant market surveillance authorities of any serious incident identified. If the provider is unreachable, Article 73 applies.
- For financial institutions, monitoring obligations are met by complying with internal governance rules under relevant financial services law.
- Keep automatically generated logs (if under your control) for a period appropriate to the intended purpose, of at least six months (unless other Union or national law, especially data protection law, provides otherwise).
- For financial institutions, maintain logs as partof the documentation kept pursuant to relevant Union financial services law.
- For employers: Before putting into service or using a high-risk AI system at the workplace, inform workers' representatives and affected workers in accordance with Union and national law and practice.
- For public authorities or Union institutions/bodies/offices/agencies: Comply with registration obligations (Art. 49). If the high-risk AI system you envisage using has not been registered in the EU database (Art. 71), do not use it and inform the provider or distributor.
- Use information provided under Article 13 to comply with Data Protection Impact Assessment (DPIA) obligations under GDPR (Art. 35) or Directive (EU) 2016/680 (Art. 27).
- For deployers of high-risk AI systems for post-remote biometric identification in law enforcement investigations: Request ex ante (or without undue delay, no later than 48 hours) authorisation by a judicial or administrative authority for use, except for initial identification of a potential suspect based on objective and verifiable facts. Each use must be strictly necessary for the investigation.
- If authorisation is rejected, stop use immediately and delete personal data related to the requested authorisation.
- Do not use such systems for untargeted law enforcement purposes, without any link to a criminal offence, criminal proceeding, genuine threat, or search for a specific missing person. Ensure no adverse legal decision is taken solely based on the system's output.
- Document each use in the relevant police file and make it available to market surveillance and national data protection authorities upon request (excluding sensitive operational data related to law enforcement).
- Submit annual reports to relevant market surveillance and national data protection authorities on the use of post-remote biometric identification systems (excluding sensitive operational data related to law enforcement).
- For Annex III high-risk AI systems making/assisting decisions related to natural persons: Inform the natural persons that they are subject to the use of the high-risk AI system (for law enforcement, Art. 13 of Directive (EU) 2016/680 applies).
- Cooperate with relevant competent authorities in any action they take to implement this Regulation.
Applies directly across all 27 EU Member States with phased entry into force from 2025 to 2026.