Table of contents

Article 6: Classification Rules for High-Risk AI Systems

Article 7: Amendments to Annex III

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

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

Article 17: Quality Management System

Article 18: Documentation Keeping

Article 19: deleted

Article 20: Automatically Generated Logs

Article 21: Corrective Actions and Duty of Information

Article 22: deleted

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

Article 29a: Fundamental Rights Impact Assessment for High-Risk AI Systems

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

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 50: Moved to Article 18

Article 51: Registration

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

Article 62: Reporting of Serious Incidents

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

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

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

Article 56: Establishment and Structure of the European Artificial Intelligence Board

1. A ‘European Artificial Intelligence Board’ (the ‘Board’) is established.

2. The Board shall be composed of one representative per Member State. The European Data Protection Supervisor, shall participate as observer. The AI Office shall also attend the Board’s meetings without taking part in the votes. Other national and Union authorities, bodies or experts may be invited to the meetings by the Board on a case by case basis, where the issues discussed are of relevance for them.

2a. Each representative shall be designated by their Member State for a period of 3 years, renewable once.

2b. Member States shall ensure that their representatives in the Board:

(a) have the relevant competences and powers in their Member State so as to contribute actively to the achievement of the Board’s tasks referred to in Article 58;

(b) are designated as a single contact point vis-à-vis the Board and, where appropriate, taking into account Member States’ needs, as a single contact point for stakeholders;

(c) are empowered to facilitate consistency and coordination between national competent authorities in their Member State as regards the implementation of this Regulation, including through the collection of relevant data and information for the purpose of fulfilling their tasks on the Board.

3. The designated representatives of the Member States shall adopt the Board’s rules of procedure by a two-thirds majority. The rules of procedure shall, in particular, lay down procedures for the selection process, duration of mandate and specifications of the tasks of the Chair, the voting modalities, and the organisation of the Board’s activities and its subgroups.

3a. The Board shall establish two standing sub-groups to provide a platform for cooperation and exchange among market surveillance authorities and notifying authorities on issues related to market surveillance and notified bodies respectively. The standing sub-group for market surveillance should act as the Administrative Cooperation Group (ADCO) for this Regulation in the meaning of Article 30 of Regulation (EU) 2019/1020. The Board may establish other standing or temporary sub-groups as appropriate for the purpose of examining specific issues. Where appropriate, representatives of the advisory forum as referred to in Article [XX] may be invited to such sub-groups or to specific meetings of those subgroups in the capacity of observers.

3b. The Board shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.

4. The Board shall be chaired by one of the representatives of the Member States. The European AI Office shall provide the Secretariat for the Board. convene the meetings upon request of the Chair and prepare the agenda in accordance with the tasks of the Board pursuant to this Regulation and its rules of procedure.