Providers of high-risk AI systems are encouraged to start to comply, on a voluntary basis, with the relevant obligations of this Regulation already during the transitional period.
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 13: Transparency and Provision of Information to Deployers
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 45: Information Obligations of Notified Bodies
Article 46: Derogation from Conformity Assessment Procedure
Section 1: Classification Rules
Section 2: Obligations for Providers of General-Purpose AI Models
Article 53: Obligations for Providers of General-Purpose AI Models
Article 54: Authorised Representatives of Providers of General-Purpose AI Models
Section 3: Obligations of Providers of General-Purpose AI Models with Systemic Risk
Article 55: Obligations for Providers of General-Purpose AI Models with Systemic Risk
Article 57: AI Regulatory Sandboxes
Article 58: Detailed Arrangements for, and Functioning of, AI Regulatory Sandboxes
Article 60: Testing of High-Risk AI Systems in Real World Conditions Outside AI Regulatory Sandboxes
Article 62: Measures for Providers and Deployers, in Particular SMEs, Including Start-Ups
Section 1: Governance at Union Level
Article 65: Establishment and Structure of the European Artificial Intelligence Board
Article 66: Tasks of the Board
Article 68: Scientific Panel of Independent Experts
Article 69: Access to the Pool of Experts by the Member States
Section 2: National Competent Authorities
Article 70: Designation of National Competent Authorities and Single Point of Contact
Section 1: Post-Market Monitoring
Section 2: Sharing of Information on Serious Incidents
Article 73: Reporting of Serious Incidents
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 79: Procedure at National Level for Dealing with AI Systems Presenting a Risk
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
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
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
Article 95: Codes of Conduct for Voluntary Application of Specific Requirements
Article 96: Guidelines from the Commission on the Implementation of this Regulation
Article 100: Administrative Fines on Union Institutions, Bodies, Offices and Agencies
Article 101: Fines for Providers of General-Purpose AI Models
Article 102: Amendment to Regulation (EC) No 300/2008
Article 103: Amendment to Regulation (EU) No 167/2013
Article 104: Amendment to Regulation (EU) No 168/2013
Article 105: Amendment to Directive 2014/90/EU
Article 106: Amendment to Directive (EU) 2016/797
Article 107: Amendment to Regulation (EU) 2018/858
Article 108: Amendments to Regulation (EU) 2018/1139
Article 109: Amendment to Regulation (EU) 2019/2144
Article 110: Amendment to Directive (EU) 2020/1828
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Annexes
Annex I: List of Union Harmonisation Legislation
Annex II: List of Criminal Offences Referred to in Article 5(1), First Subparagraph, Point (h)(iii)
Annex III: High-Risk AI Systems Referred to in Article 6(2)
Annex IV: Technical Documentation Referred to in Article 11(1)
Annex V: EU Declaration of Conformity
Annex VI: Conformity Assessment Procedure Based on Internal Control
Search within the Act
Recital 178
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.
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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)