Table of contents

Chapter 1: Classification of AI Systems as High-Risk

Article 6: Classification Rules for High-Risk AI Systems

Article 7: Amendments to Annex III

Chapter 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

Chapter 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 20: Automatically Generated Logs

Article 21: Corrective Actions and Duty of Information

Article 23: Cooperation with Competent Authorities

Article 25: Authorised Representatives

Article 26: Obligations of Importers

Article 27: Obligations of Distributors

Article 28: Responsibilities Along the AI Value Chain

Article 29: Obligations of Deployers of High-Risk AI Systems

Chapter 4: Notifying Authorities and Notified Bodies

Article 30: Notifying Authorities

Article 31: Application of a Conformity Assessment Body for Notification

Article 32: Notification Procedure

Article 33: Requirements Relating to Notified Bodies

Article 33a: Presumption of Conformity with Requirements Relating to Notified Bodies

Article 34: Subsidiaries of and Subcontracting by Notified Bodies

Article 34a: 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

Chapter 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 46: Information Obligations of Notified Bodies

Article 47: Derogation from Conformity Assessment Procedure

Article 48: EU Declaration of Conformity

Article 49: CE Marking of Conformity

Article 51: Registration

Chapter 1: Post-Market Monitoring

Article 61: Post-Market Monitoring by Providers and Post-Market Monitoring Plan for High-Risk AI Systems

Chapter 2: Sharing of Information on Serious Incidents

Article 62: Reporting of Serious Incidents

Chapter 3: Enforcement

Article 63: Market Surveillance and Control of AI Systems in the Union Market

Article 63a: Mutual Assistance, Market Surveillance and Control of General Purpose AI Systems

Article 63b: Supervision of Testing in Real World Conditions by Market Surveillance Authorities

Article 64: Powers of Authorities Protecting Fundamental Rights

Article 65: Procedure for Dealing with AI Systems Presenting a Risk at National Level

Article 65a: Procedure for Dealing with AI Systems Classified by the Provider as a Not High-Risk in Application of Annex III

Article 66: Union Safeguard Procedure

Article 67: Compliant AI Systems Which Present a Risk

Article 68: Formal Non-Compliance

Article 68a: EU AI Testing Support Structures in the Area of Artificial Intelligence

Chapter 3b: Remedies

Article 68a(1): Right to Lodge a Complaint with a Market Surveillance Authority

Article 68c: A Right to Explanation of Individual Decision-Making

Article 68d: Amendment to Directive (EU) 2020/1828

Article 68e: Reporting of Breaches and Protection of Reporting Persons

Chapter 3c: Supervision, Investigation, Enforcement and Monitoring in Respect of Providers of General Purpose AI Models

Article 68f: Enforcement of Obligations on Providers of General Purpose AI Models

Article 68g : Monitoring Actions

Article 68h: Alerts of Systemic Risks by the Scientific Panel

Article 68i: Power to Request Documentation and Information

Article 68j: Power to Conduct Evaluations

Article 68k: Power to Request Measures

Article 68m: Procedural Rights of Economic Operators of the General Purpose AI Model

Recital 72

The objectives of the AI regulatory sandboxes should be to foster AI innovation by establishing a controlled experimentation and testing environment in the development and pre-marketing phase with a view to ensuring compliance of the innovative AI systems with this Regulation and other relevant Union and Member States legislation, to enhance legal certainty for innovators and the competent authorities’ oversight and understanding of the opportunities, emerging risks and the impacts of AI use, to facilitate regulatory learning for authorities and companies, including with a view to future adaptions of the legal framework, to support cooperation and the sharing of best practices with the authorities involved in the AI regulatory sandbox, and to accelerate access to markets, including by removing barriers for small and medium enterprises (SMEs), including start-ups. Regulatory sandboxes should be widely available throughout the Union, and particular attention should be given to their accessibility for SMEs, including start-ups. The participation in the AI regulatory sandbox should focus on issues that raise legal uncertainty for providers and prospective providers to innovate, experiment with AI in the Union and contribute to evidence-based regulatory learning. The supervision of the AI systems in the AI regulatory sandbox should therefore cover their development, training, testing and validation before the systems are placed on the market or put into service, as well as the notion and occurrence of substantial modification that may require a new conformity assessment procedure. Any significant risks identified during the development and testing of such AI systems should result in adequate mitigation and, failing that, in the suspension of the development and testing process Where appropriate, national competent authorities establishing AI regulatory sandboxes should cooperate with other relevant authorities, including those supervising the protection of fundamental rights,, and could allow for the involvement of other actors within the AI ecosystem such as national or European standardisation organisations, notified bodies, testing and experimentation facilities, research and experimentation labs, European Digital innovation hubs and relevant stakeholder and civil society organisations. To ensure uniform implementation across the Union and economies of scale, it is appropriate to establish common rules for the regulatory sandboxes’ implementation and a framework for cooperation between the relevant authorities involved in the supervision of the sandboxes. AI regulatory sandboxes established under this Regulation should be without prejudice to other legislation allowing for the establishment of other sandboxes aiming at ensuring compliance with legislation other that this Regulation. Where appropriate, relevant competent authorities in charge of those other regulatory sandboxes should consider the benefits of using those sandboxes also for the purpose of ensuring compliance of AI systems with this Regulation. Upon agreement between the national competent authorities and the participants in the AI regulatory sandbox, testing in real world conditions may also be operated and supervised in the framework of the AI regulatory sandbox.