Chapter III: HIGH-RISK AI SYSTEMS
Article 6 to 49 of Regulation (EU) 2024/1689.
Section 1: Classification of AI systems as high-risk
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