Title III High-Risk AI System
Article 34a: Operational Obligations of Notified Bodies
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Article 35: Identification Numbers and Lists of Notified Bodies Designated Under this Regulation
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Table of content
- Title I General Provisions Art 1 - 4b
- Title II Prohibited Artificial Intelligence Practices Art 5 - 5
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Title III
High-Risk AI System
Art 6 - 51
- Article 6: Classification Rules for High-Risk AI Systems
- Article 7: Amendments to Annex III
- 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
- Article 16: Obligations of Providers of High-Risk AI Systems
- Article 17: Quality Management System
- Article 18: Documentation Keeping
- Article 20: Automatically Generated Logs
- Article 21: Corrective Actions and Duty of Information
- Article 23: Cooperation with Competent Authorities
- Article 25: Authorised Representatives
- Article 26: Obligations of Importers
- Article 27: Obligations of Distributors
- Article 28: Responsibilities Along the AI Value Chain
- Article 29: Obligations of Deployers of High-Risk AI Systems
- Article 29a: Fundamental Rights Impact Assessment for High-Risk AI Systems
- Article 30: Notifying Authorities
- Article 31: Application of a Conformity Assessment Body for Notification
- Article 32: Notification Procedure
- Article 33: Requirements Relating to Notified Bodies
- Article 33a: Presumption of Conformity with Requirements Relating to Notified Bodies
- Article 34: Subsidiaries of and Subcontracting by Notified Bodies
- Article 34a: Operational Obligations of 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
- 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 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 51: Registration
- Title IV Transparency Obligations for Providers and Deployers of Certain AI Systems and GPAI Models Art 52 - 52
- Title IX Codes of Conduct Art 69 - 69
- Title V Measures in Support of Innovation Art 53 - 55
- Title VI Governance Art 55b - 59
- Title VII EU Database for High-Risk AI Systems Listed in Annex III Art 60 - 60
- Title VIII Post-Market Monitoring, Information Sharing, Market Surveillance Art 61 - 68a-2
- Title VIIIA General Purpose AI Models Art 52a - 52e
- Title X Confidentiality and Penalties Art 70 - 72a
- Title XI Delegation of Power and Committee Procedure Art 73 - 74
- Title XII Final Provisions Art 75 - 85
