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

Recital 47

To address concerns related to opacity and complexity of certain AI systems and help deployers to fulfil their obligations under this Regulation, transparency should be required for high-risk AI systems before they are placed on the market or put it into service. High- risk AI systems should be designed in a manner to enable deployers to understand how the AI system works, evaluate its functionality, and comprehend its strengths and limitations. High risk AI systems, should be accompanied by appropriate information in the form of instructions of use. Such information should include the characteristics, capabilities and limitations of performance of the AI system. These would cover information on possible known and foreseeable circumstances related to the use of the high-risk AI system, including deployer action that may influence system behaviour and performance, under which the AI system can lead to risks to health, safety, and fundamental rights, on the changes that have been pre-determined and assessed for conformity by the provider and on the relevant human oversight measures, including the measures to facilitate the interpretation of the outputs of the AI system by the deployers. Transparency, including the accompanying instructions for use, should assist deployers in the use of the system and support informed decision making by them. Among others, deployers should be in a better position to make the correct choice of the system they intend to use in the light of the obligations applicable to them, be educated about the intended and precluded uses, and use the AI system correctly and as appropriate. In order to enhance legibility and accessibility of the information included in the instructions of use, where appropriate, illustrative examples, for instance on the limitations and on the intended and precluded uses of the AI system, should be included. Providers should ensure that all documentation, including the instructions for use, contains meaningful, comprehensive, accessible and understandable information, taking into account the needs and foreseeable knowledge of the target deployers. Instructions for use should be made available in a language which can be easily understood by target deployers, as determined by the Member State concerned.