Chapter 1: Classification of Systems as High-Risk
Article 7: Amendments to Annex III
Chapter 2: Requirements for High-Risk AI Systems
Article 8: Compliance with the requirements
Article 9: Risk management system
Article 10: Data and data governance
Article 11: Technical documentation
Article 13: Transparency and provision of information to users
Article 15: Accuracy, robustness and cybersecurity
Chapter 3: Obligations of Users of High-Risk AI Systems and other Parties
Article 16: Obligations of providers of high-risk AI systems
Article 17: Quality management system
Article 18: Obligation to draw up technical documentation
Article 19: Conformity assessment
Article 20: Automatically generated logs
Article 21: Corrective actions
Article 22: Duty of information
Article 23: Cooperation with competent authorities
Article 24: Obligations of product manufacturers
Article 25: Authorised representatives
Article 26: Obligations of importers
Article 27: Obligations of distributors
Article 28: Obligations of distributors, importers, users or any other third-party
Article 29: Obligations of users of high-risk AI systems
Chapter 4: Notifying Authorities and Notified Bodies
Article 30: Notifying authorities
Article 31: Application of a conformity assessment body for notification
Article 32: Notification procedure
Article 34: Subsidiaries of and subcontracting by 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
Chapter 5: Standards, Conformity Assessment, Certificates, Registration
Article 40: Harmonised standards
Article 41: Common specifications
Article 42: Presumption of conformity with certain requirements
Article 43: Conformity assessment
Article 45: Appeal against decisions of notified bodies
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