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 26: Obligations of Importers

1. Before placing a high-risk AI system on the market, importers of such system shall ensure that such a system is in conformity with this Regulation by verifying that:

(a) the relevant conformity assessment procedure referred to in Article 43 has been carried out by the provider of that AI system;

(b) the provider has drawn up the technical documentation in accordance with Article 11 and Annex IV;

(c) the system bears the required CE conformity marking and is accompanied by the EU declaration of conformity and instructions of use;

(ca) the provider has appointed an authorised representative in accordance with Article 25(1).

2. Where an importer has sufficient reason to consider that a high-risk AI system is not in conformity with this Regulation, or is falsified, or accompanied by falsified documentation, it shall not place that system on the market until that AI system has been brought into conformity. Where the high-risk AI system presents a risk within the meaning of Article 65(1), the importer shall inform the provider of the AI system , the authorised representatives and the market surveillance authorities to that effect.

3. Importers shall indicate their name, registered trade name or registered trade mark, and the address at which they can be contacted on the high-risk AI system and on its packaging or its accompanying documentation, where applicable.

4. Importers shall ensure that, while a high-risk AI system is under their responsibility, where applicable, storage or transport conditions do not jeopardise its compliance with the requirements set out in Chapter 2 of this Title.

4a. Importers shall keep, for a period ending 10 years after the AI system has been placed on the market or put into service, a copy of the certificate issued by the notified body, where applicable, of the instructions for use and of the EU declaration of conformity.

5. Importers shall provide national competent authorities, upon a reasoned request, with all the necessary information and documentation including that kept in accordance with paragraph 4a to demonstrate the conformity of a high-risk AI system with the requirements set out in Chapter 2 of this Title in a language which can be easily understood by them. To this purpose they shall also ensure that the technical documentation can be made available to those authorities.

5a. Importers shall cooperate with national competent authorities on any action those authorities take, in particular to reduce and mitigate the risks posed by the high-risk AI system.