Title III: High-Risk AI Systems

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 12: Record-keeping

Article 13: Transparency and provision of information to users

Article 14: Human oversight

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 33: Notified bodies

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 44: Certificates

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

Article 50: Document retention

Article 51: Registration