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

Annex VIII: Information to be Submitted upon the Registration of High-Risk AI Systems in Accordance with Article 51


Section A: – Information to be submitted by providers of high-risk AI systems in accordance with Article 51(1)

The following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be registered in accordance with Article 51 (1):

1. Name, address and contact details of the provider.

2. Where submission of information is carried out by another person on behalf of the provider, the name, address and contact details of that person.

3. Name, address and contact details of the authorised representative, where applicable.

4. AI system trade name and any additional unambiguous reference allowing identification and traceability of the AI system.

5. Description of the intended purpose of the AI system and of the components and functions supported through this AI system;

5a. A basic and concise description of the information used by the system (data, inputs) and its operating logic.

6. Status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled).

7. Type, number and expiry date of the certificate issued by the notified body and the name or identification number of that notified body, when applicable.

8. A scanned copy of the certificate referred to in point 7, when applicable.

9. Member States in which the AI system is or has been placed on the market, put into service or made available in the Union.

10. A copy of the EU declaration of conformity referred to in Article 48.

11. Electronic instructions for use; this information shall not be provided for high-risk AI systems in the areas of law enforcement and migration, asylum and border control management referred to in Annex III, points 1, 6 and 7.

12. URL for additional information (optional).


Section B: Information to be submitted by deployers of high-risk AI systems in accordance with Article 51(1b)

The following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be registered in accordance with Article 51:

1. The name, address and contact details of the deployer.

2. The name, address and contact details of the person submitting information on behalf of the deployer.

5. A summary of the findings of the fundamental rights impact assessment conducted in accordance with Article 29a.

6. The URL of the entry of the AI system in the EU database by its provider.

7. A summary of the data protection impact assessment carried out in accordance with Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680 as specified in paragraph 6 of Article 29 of this Regulation, where applicable.


Section C: Information to be Submitted upon the Registration of High-Risk AI Systems in Accordance with Article 51(1a)

The following information shall be provided and thereafter kept up to date with regard to AI systems to be registered in accordance with Article 51(1a):

1. Name, address and contact details of the provider.

1. Where submission of information is carried out by another person on behalf of the provider, the name, address and contact details of that person.

2. Name, address and contact details of the authorised representative, where applicable.

3. AI system trade name and any additional unambiguous reference allowing identification and traceability of the AI system.

4. Description of the intended purpose of the AI system.

5. Based on which criterion or criteria provided in Article 6(2a) the AI system is considered as not high-risk.

6. Short summary of the grounds for considering the AI system as not high-risk in application of the procedure under Article 6(2a).

7. Status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled); Member States in which the AI system is or has been placed on the market, put into service or made available in the Union.