Table of contents

Section 1: Classification of AI Systems as High-Risk

Article 6: Classification Rules for High-Risk AI Systems

Article 7: Amendments to Annex III

Section 2: Requirements for High-Risk AI Systems

Article 8: Compliance with the Requirements

Article 9: Risk Management System

Article 10: Data and Data Governance

Article 11: Technical Documentation

Article 12: Record-Keeping

Article 13: Transparency and Provision of Information to Deployers

Article 14: Human Oversight

Article 15: Accuracy, Robustness and Cybersecurity

Section 3: Obligations of Providers and Deployers of High-Risk AI Systems and Other Parties

Article 16: Obligations of Providers of High-Risk AI Systems

Article 17: Quality Management System

Article 18: Documentation Keeping

Article 19: Automatically Generated Logs

Article 20: Corrective Actions and Duty of Information

Article 21: Cooperation with Competent Authorities

Article 22: Authorised Representatives of providers of high-risk AI systems

Article 23: Obligations of Importers

Article 24: Obligations of Distributors

Article 25: Responsibilities Along the AI Value Chain

Article 26: Obligations of Deployers of High-Risk AI Systems

Article 27: Fundamental Rights Impact Assessment for High-Risk AI Systems

Section 4: Notifying Authorities and Notified Bodies

Article 28: Notifying Authorities

Article 29: Application of a Conformity Assessment Body for Notification

Article 30: Notification Procedure

Article 31: Requirements Relating to Notified Bodies

Article 32: Presumption of Conformity with Requirements Relating to Notified Bodies

Article 33: Subsidiaries of and Subcontracting by Notified Bodies

Article 34: Operational Obligations of Notified Bodies

Article 35: Identification Numbers and Lists of Notified Bodies Designated Under this Regulation

Article 36: Changes to Notifications

Article 37: Challenge to the Competence of Notified Bodies

Article 38: Coordination of Notified Bodies

Article 39: Conformity Assessment Bodies of Third Countries

Section 5: Standards, Conformity Assessment, Certificates, Registration

Article 40: Harmonised Standards and Standardisation Deliverables

Article 41: Common Specifications

Article 42: Presumption of Conformity with Certain Requirements

Article 43: Conformity Assessment

Article 44: Certificates

Article 45: Information Obligations of Notified Bodies

Article 46: Derogation from Conformity Assessment Procedure

Article 47: EU Declaration of Conformity

Article 48: CE Marking

Article 49: Registration

Section 1: Post-Market Monitoring

Article 72: Post-Market Monitoring by Providers and Post-Market Monitoring Plan for High-Risk AI Systems

Section 2: Sharing of Information on Serious Incidents

Article 73: Reporting of Serious Incidents

Section 3: Enforcement

Article 74: Market Surveillance and Control of AI Systems in the Union Market

Article 75: Mutual Assistance, Market Surveillance and Control of General Purpose AI Systems

Article 76: Supervision of Testing in Real World Conditions by Market Surveillance Authorities

Article 77: Powers of Authorities Protecting Fundamental Rights

Article 78: Confidentiality

Article 79: Procedure for Dealing with AI Systems Presenting a Risk at National Level

Article 80: Procedure for Dealing with AI Systems Classified by the Provider as a Not High-Risk in Application of Annex III

Article 81: Union Safeguard Procedure

Article 82: Compliant AI Systems Which Present a Risk

Article 83: Formal Non-Compliance

Article 84: Union AI Testing Support Structures

Section 4: Remedies

Article 85: Right to Lodge a Complaint with a Market Surveillance Authority

Article 86: A Right to Explanation of Individual Decision-Making

Article 87: Reporting of Breaches and Protection of Reporting Persons

Section 5: Supervision, Investigation, Enforcement and Monitoring in Respect of Providers of General Purpose AI Models

Article 88: Enforcement of Obligations on Providers of General Purpose AI Models

Article 89 : Monitoring Actions

Article 90: Alerts of Systemic Risks by the Scientific Panel

Article 91: Power to Request Documentation and Information

Article 92: Power to Conduct Evaluations

Article 93: Power to Request Measures

Article 94: Procedural Rights of Economic Operators of the General Purpose AI Model

Annexes

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Article 26: Obligations of Deployers of High-Risk AI Systems

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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 of use accompanying the systems, pursuant to paragraphs 2 and 5 of this Article.

1a. Deployers shall assign human oversight to natural persons who have the necessary competence, training and authority, as well as the necessary support.

1a. To the extent deployers exercise control over the high-risk AI system, they shall ensure that the natural persons assigned to ensure human oversight of the high-risk AI systems have the necessary competence, training and authority as well as the necessary support.

2. The obligations in paragraph 1 and 1a, are without prejudice to other deployer obligations under Union or national law and to the deployer’s discretion in organising its own resources and activities for the purpose of implementing the human oversight measures indicated by the provider.

3. Without prejudice to paragraph 1 and 1a, to the extent the deployer exercises control over the input data, that deployer shall ensure that input data is relevant and sufficiently representative in view of the intended purpose of the high-risk AI system.

4. Deployers shall monitor the operation of the high-risk AI system on the basis of the instructions of use and when relevant, inform providers in accordance with Article 72. When they have reasons to consider that the use in accordance with the instructions of use may result in the AI system presenting a risk within the meaning of Article 79(1) they shall, without undue delay, inform the provider or distributor and relevant market surveillance authority and suspend the use of the system. They shall also immediately inform first the provider, and then the importer or distributor and relevant market surveillance authorities when they have identified any serious 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 users of AI systems which are law enforcement authorities. For deployers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services legislation, the monitoring obligation set out 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 legislation.

5. 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 period appropriate to the intended purpose of the high-risk AI system, of at least six months, unless provided otherwise in applicable Union or national law, in particular in Union law on the protection of personal data.

Deployers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services legislation shall maintain the logs as part of the documentation kept pursuant to the relevant Union financial service legislation.

(a) Prior to putting into service or use a high-risk AI system at the workplace, deployers who are employers shall inform workers representatives and the affected workers that they will be subject to the 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.

(b) Deployers of high-risk AI systems that are public authorities or Union institutions, bodies, offices and agencies shall comply with the registration obligations referred to in Article 49. When they find that the system that they envisage to use has not been registered in the EU database referred to in Article 71 they shall not use that system and shall inform the provider or the distributor.

(c) Deployers of high-risk AI systems that are public authorities, including Union institutions, bodies, offices and agencies referred to in Article 49(1a)(b) shall comply with the registration obligations referred to in Article 49.

6. Where applicable, deployers of high-risk AI systems shall use the information provided under Article 13 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.

6a. Without prejudice to Directive (EU) 2016/680, in the framework of an investigation for the targeted search of a person convicted or suspected of having committed a criminal offence, the deployer of an AI system for post remote biometric identification shall request an authorisation, prior, or without undue delay and no later than 48hours, by a judicial authority or an administrative authority whose decision is binding and subject to judicial review, for the use of the system, except when the system is used for the initial identification of a potential suspect based on objective and verifiable facts directly linked to the offence. Each use shall be limited to what is strictly necessary for the investigation of a specific criminal offence. If the requested authorisation provided for in the first subparagraph of this paragraph is rejected, the use of the post remote biometric identification system linked to that authorisation shall be stopped with immediate effect and the personal data linked to the use of the system for which the authorisation was requested shall be deleted. In any case, such AI system for post remote biometric identification shall not be used for law enforcement purposes in an untargeted way, without any link to a criminal offence, a criminal proceeding, a genuine and present or genuine and foreseeable threat of a criminal offence or the search for a specific missing person. It shall be ensured that no decision that produces an adverse legal effect on a person may be taken by the law enforcement authorities solely based on the output of these post remote biometric identification systems. This paragraph is without prejudice to the provisions of Article 10 of the Directive (EU) 2016/680 and Article 9 of the GDPR for the processing of biometric data. Regardless of the purpose or deployer, each use of these 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 data related to law enforcement. This subparagraph shall be without prejudice to the powers conferred by the Directive 2016/680 to supervisory authorities. Deployers shall, in addition, submit annual reports to the relevant market surveillance and national data protection authorities on the uses of post remote biometric identification systems, excluding the disclosure of sensitive operational data related to law enforcement. The reports can be aggregated to cover several deployments in one operation. Member States may introduce, in accordance with Union law, more restrictive laws on the use of post remote biometric identification systems.

6b. Without prejudice to Article 50, 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 they are subject to the use of the high-risk AI system. For high risk AI systems used for law enforcement purposes Article 13 of Directive 2016/680 shall apply.

6c. Deployers shall cooperate with the relevant national competent authorities on any action those authorities take in relation with the high-risk system in order to implement this Regulation.

The text used in this tool is the ‘Artificial Intelligence Act, Text of the provisional agreement, 2 February 2024’, which was officially announced in this press release. Interinstitutional File: 2021/0106(COD)

Where new Articles have been added in later versions, and important fixes have been made, these changes have been replicated in the AI Act Explorer too. Also, in the 'Texts Adopted' from March 2024, many items were re-named or re-numbered, and items in the AI Act Explorer were updated accordingly. This means the content on our site no longer matches exactly with any official AI Act draft – it is a hybrid of multiple drafts. If you find an important update in a later draft that has not been updated in our tool, please let us know.

When a final draft is available, all of the text in the AI Act Explorer will be updated to reflect it.