Article 1: Subject Matter

Article 2: Scope

Article 3: Definitions

Article 4: AI literacy

Article 5: Prohibited Artificial Intelligence Practices

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

Article 50: Transparency Obligations for Providers and Users of Certain AI Systems and GPAI Models

Section 1: Classification Rules

Article 51: Classification of General-Purpose AI Models as General Purpose AI Models with Systemic Risk

Article 52: Procedure

Section 2: Obligations for Providers of General Purpose AI Models

Article 53: Obligations for Providers of General-Purpose AI Models

Article 54: Authorised Representative

Section 3: Obligations for Providers of General Purpose AI Models with Systemic Risk

Article 55: Obligations for Providers of General-Purpose AI Models with Systemic Risk

Article 56: Codes of Practice

Article 57: AI Regulatory Sandboxes

Article 58: Detailed arrangements for and functioning of AI regulatory sandboxes

Article 59: Further Processing of Personal Data for Developing Certain AI Systems in the Public Interest in the AI Regulatory Sandbox

Article 60: Testing of High-Risk AI Systems in Real World Conditions Outside AI Regulatory Sandboxes

Article 61: Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes

Article 62: Measures for Providers and Deployers, in Particular SMEs, Including Start-Ups

Article 63: Derogations for specific operators

Section 1: Governance at Union Level

Article 64: AI Office

Article 65: Establishment and Structure of the European Artificial Intelligence Board

Article 66: Tasks of the Board

Article 67: Advisory Forum

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

Article 71: EU Database for High-Risk AI Systems Listed in Annex III

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

Article 95: Codes of Conduct for Voluntary Application of Specific Requirements

Article 96: Guidelines from the Commission on the Implementation of this Regulation

Article 97: Exercise of the Delegation

Article 98: Committee Procedure

Article 99: Penalties

Article 100: Administrative Fines on Union Institutions, Agencies and Bodies

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: Amendment to Regulation (EU) 2018/1139

Article 109: Amendment to Regulation (EU) 2019/2144

Article 110: Amendment to Directive (EU) 2020/1828

Article 111: AI Systems Already Placed on the Market or put into Service

Article 112: Evaluation and Review

Article 113: Entry into Force and Application

Annex I: List of Union Harmonisation Legislation

Annex II: List of Criminal Offences

Annex III: High-Risk AI Systems

Annex IV: Technical Documentation

Annex V: EU Declaration of Conformity

Annex VI: Conformity Assessment Procedure Based on Internal Control

Annex VII: Conformity Based on Assessment of Quality Management System and Assessment of Technical Documentation

Annex VIII: Information to be Submitted upon the Registration of High-Risk AI Systems (Article 49)

Annex IX: Information to be Submitted upon the Registration of High-Risk AI Systems (Annex III / Article 60)

Annex X: Union Legislation on Large-Scale IT Systems in the Area of Freedom, Security and Justice

Annex XI: Technical Documentation Referred to in Article 53(1a)

Annex XII: Transparency Information Referred to in Article 53(1b)

Annex XIII: Criteria for the Designation of General Purpose AI models with Systemic Risk