Chapter 3

High-Risk AI Systems

SECTION 1: Classification of AI systems as high-risk

Article 6: Classification rules for high-risk AI systems

Article 7: Amendments to Annex III

SECTION 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 deployers

Article 14: Human oversight

Article 15: Accuracy, robustness and cybersecurity

SECTION 3: Obligations of providers and deployers 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: Documentation keeping

Article 19: Automatically generated logs

Article 20: Corrective actions and duty of information

Article 21: Cooperation with competent authorities

Article 22: Authorised representatives of providers of high-risk AI systems

Article 23: Obligations of importers

Article 24: Obligations of distributors

Article 25: Responsibilities along the AI value chain

Article 26: Obligations of deployers of high-risk AI systems

Article 27: Fundamental rights impact assessment for high-risk AI systems

SECTION 4: Notifying authorities and notified bodies

Article 28: Notifying authorities

Article 29: Application of a conformity assessment body for notification

Article 30: Notification procedure

Article 31: Requirements relating to notified bodies

Article 32: Presumption of conformity with requirements relating to notified bodies

Article 33: Subsidiaries of notified bodies and subcontracting

Article 34: Operational obligations of notified bodies

Article 35: Identification numbers and lists of notified bodies

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

SECTION 5: Standards, conformity assessment, certificates, registration

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 45: Information obligations of notified bodies

Article 46: Derogation from conformity assessment procedure

Article 47: EU declaration of conformity

Article 48: CE marking

Article 49: Registration

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