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 Notified Bodies and Subcontracting

Article 34: Operational Obligations of Notified Bodies

Article 35: Identification Numbers and Lists of Notified Bodies

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 at National Level for Dealing with AI Systems Presenting a Risk

Article 80: Procedure for Dealing with AI Systems Classified by the Provider as Non-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: Right to Explanation of Individual Decision-Making

Article 87: Reporting of Infringements 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 the Obligations of 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

Recitals

Annexes

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Recital 158

NOTE: This translation is a machine-generated translation. It is not the official translation provided by the European Parliament. When the AI Act is published in the official journal, the machine-generated translations will be replaced by the official translations.

Union financial services law includes internal governance and risk-management rules and requirements which are applicable to regulated financial institutions in the course of provision of those services, including when they make use of AI systems. In order to ensure coherent application and enforcement of the obligations under this Regulation and relevant rules and requirements of the Union financial services legal acts, the competent authorities for the supervision and enforcement of those legal acts, in particular competent authorities as defined in Regulation (EU) No 575/2013 of the European Parliament and of the Council[46] and Directives 2008/48/EC[47], 2009/138/EC[48], 2013/36/EU[49], 2014/17/EU[50] and (EU) 2016/97[51] of the European Parliament and of the Council, should be designated, within their respective competences, as competent authorities for the purpose of supervising the implementation of this Regulation, including for market surveillance activities, as regards AI systems provided or used by regulated and supervised financial institutions unless Member States decide to designate another authority to fulfil these market surveillance tasks. Those competent authorities should have all powers under this Regulation and Regulation (EU) 2019/1020 to enforce the requirements and obligations of this Regulation, including powers to carry our ex post market surveillance activities that can be integrated, as appropriate, into their existing supervisory mechanisms and procedures under the relevant Union financial services law. It is appropriate to envisage that, when acting as market surveillance authorities under this Regulation, the national authorities responsible for the supervision of credit institutions regulated under Directive 2013/36/EU, which are participating in the Single Supervisory Mechanism established by Council Regulation (EU) No 1024/2013[52], should report, without delay, to the European Central Bank any information identified in the course of their market surveillance activities that may be of potential interest for the European Central Bank’s prudential supervisory tasks as specified in that Regulation. To further enhance the consistency between this Regulation and the rules applicable to credit institutions regulated under Directive 2013/36/EU, it is also appropriate to integrate some of the providers’ procedural obligations in relation to risk management, post marketing monitoring and documentation into the existing obligations and procedures under Directive 2013/36/EU. In order to avoid overlaps, limited derogations should also be envisaged in relation to the quality management system of providers and the monitoring obligation placed on deployers of high-risk AI systems to the extent that these apply to credit institutions regulated by Directive 2013/36/EU. The same regime should apply to insurance and re-insurance undertakings and insurance holding companies under Directive 2009/138/EC and the insurance intermediaries under Directive (EU) 2016/97 and other types of financial institutions subject to requirements regarding internal governance, arrangements or processes established pursuant to the relevant Union financial services law to ensure consistency and equal treatment in the financial sector.

[46] Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1).

[47] Directive 2008/48/EC of the European Parliament and of the Council of 23 April 2008 on credit agreements for consumers and repealing Council Directive 87/102/EEC (OJ L 133, 22.5.2008, p. 66).

[48] Directive 2009/138/EC of the European Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (OJ L 335, 17.12.2009, p. 1).

[49] Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338).

[50] Directive 2014/17/EU of the European Parliament and of the Council of 4 February 2014 on credit agreements for consumers relating to residential immovable property and amending Directives 2008/48/EC and 2013/36/EU and Regulation (EU) No 1093/2010 (OJ L 60, 28.2.2014, p. 34).

[51] Directive (EU) 2016/97 of the European Parliament and of the Council of 20 January 2016 on insurance distribution (OJ L 26, 2.2.2016, p. 19).

[52] Council Regulation (EU) No 1024/2013 of 15 October 2013 conferring specific tasks on the European Central Bank concerning policies relating to the prudential supervision of credit institutions (OJ L 287, 29.10.2013, p. 63).

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View the official text, or browse it online using our AI Act Explorer. The text used in this tool is the ‘Artificial Intelligence Act (Regulation (EU) 2024/1689), Official Journal version of 13 June 2024’. Interinstitutional File: 2021/0106(COD)