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Chapter III: High-Risk AI Systems

Articles 6–49 of Regulation (EU) 2024/1689.

What this part of the EU AI Act covers

Chapter III is the longest and most demanding part of the Regulation. It decides which AI systems count as high-risk, sets the requirements those systems must meet, allocates duties across providers, deployers, importers and distributors, builds the notified-body infrastructure that assesses conformity, and governs standards, certification and registration.

It binds providers most heavily, but also deployers, importers, distributors and notified bodies, each with distinct duties. What it produces is an evidence file: a risk management record, data governance documentation, technical documentation to the Annex IV specification, logs, instructions for use, and a declaration of conformity: the artefacts a market surveillance authority asks for.

All 44 provisions

Art. 6Classification Rules for High-risk AI Systems Art. 7Amendments to Annex III Art. 8Compliance with the Requirements Art. 9Risk Management System Art. 10Data and Data Governance Art. 11Technical Documentation Art. 12Record-Keeping Art. 13Transparency and Provision of Information to Deployers Art. 14Human Oversight Art. 15Accuracy, Robustness and Cybersecurity Art. 16Obligations of Providers of High-Risk AI Systems Art. 17Quality Management System Art. 18Documentation Keeping Art. 19Automatically Generated Logs Art. 20Corrective Actions and Duty of Information Art. 21Cooperation with Competent Authorities Art. 22Authorised Representatives of Providers of High-Risk AI Systems Art. 23Obligations of Importers Art. 24Obligations of Distributors Art. 25Responsibilities Along the AI Value Chain Art. 26Obligations of Deployers of High-Risk AI Systems Art. 27Fundamental Rights Impact Assessment for High-risk AI Systems Art. 28Notifying Authorities Art. 29Application of A Conformity Assessment Body for Notification Art. 30Notification Procedure Art. 31Requirements Relating to Notified Bodies Art. 32Presumption of Conformity with Requirements Relating to Notified Bodies Art. 33Subsidiaries of Notified Bodies and Subcontracting Art. 34Operational Obligations of Notified Bodies Art. 35Identification Numbers and Lists of Notified Bodies Art. 36Changes to Notifications Art. 37Challenge to the Competence of Notified Bodies Art. 38Coordination of Notified Bodies Art. 39Conformity Assessment Bodies of Third Countries Art. 40Harmonised Standards and Standardisation Deliverables Art. 41Common Specifications Art. 42Presumption of Conformity with Certain Requirements Art. 43Conformity Assessment Art. 44Certificates Art. 45Information Obligations of Notified Bodies Art. 46Derogation from Conformity Assessment Procedure Art. 47EU Declaration of Conformity Art. 48CE Marking Art. 49Registration

All 44 provisions on this page have been checked against the EUR-Lex text of Regulation (EU) 2024/1689. Where this site and EUR-Lex disagree, EUR-Lex governs.

Where to go next

Section 1: Classification of AI Systems as High-RiskArticles 6–7 Section 2: Requirements for High-Risk AI SystemsArticles 8–15 Section 3: Obligations of Providers and DeployersArticles 16–27 Section 4: Notifying Authorities and Notified BodiesArticles 28–39 Section 5: Standards, Conformity Assessment, Certificates and RegistrationArticles 40–49 Chapter II: Prohibited AI PracticesPrevious chapter Chapter IV: Transparency ObligationsNext chapter Full EU AI Act table of contentsAll 13 chapters