Chapter 3: High-Risk AI System

Section 1

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Classification of AI Systems as High-Risk

Article 6

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Classification Rules for High-Risk AI Systems

Article 7

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Amendments to Annex III

Section 2

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Requirements for High-Risk AI Systems

Article 8

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Compliance with the Requirements

Article 9

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Risk Management System

Article 10

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Data and Data Governance

Article 11

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Technical Documentation

Transparency and Provision of Information to Deployers

Accuracy, Robustness and Cybersecurity

Section 3

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Obligations of Providers and Deployers of High-Risk AI Systems and Other Parties

Article 16

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Obligations of Providers of High-Risk AI Systems

Article 17

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Quality Management System

Article 18

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Documentation Keeping

Article 19

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Automatically Generated Logs

Article 20

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Corrective Actions and Duty of Information

Article 21

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Cooperation with Competent Authorities

Article 22

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Authorised Representatives of Providers of High-Risk AI Systems

Article 23

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Obligations of Importers

Article 24

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Obligations of Distributors

Article 25

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Responsibilities Along the AI Value Chain

Article 26

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Obligations of Deployers of High-Risk AI Systems

Article 27

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Fundamental Rights Impact Assessment for High-Risk AI Systems

Section 4

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Notifying Authorities and Notified Bodies

Article 28

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Notifying Authorities

Article 29

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Application of a Conformity Assessment Body for Notification

Article 30

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Notification Procedure

Article 31

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Requirements Relating to Notified Bodies

Article 32

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Presumption of Conformity with Requirements Relating to Notified Bodies

Article 33

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Subsidiaries of Notified Bodies and Subcontracting

Article 34

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Operational Obligations of Notified Bodies

Article 35

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Identification Numbers and Lists of Notified Bodies

Article 36

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Changes to Notifications

Article 37

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Challenge to the Competence of Notified Bodies

Article 38

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Coordination of Notified Bodies

Article 39

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Conformity Assessment Bodies of Third Countries

Section 5

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Standards, Conformity Assessment, Certificates, Registration

Article 40

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Harmonised Standards and Standardisation Deliverables

Article 41

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Common Specifications

Article 42

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Presumption of Conformity with Certain Requirements

Article 43

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Conformity Assessment

Information Obligations of Notified Bodies

Article 46

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Derogation from Conformity Assessment Procedure

Article 47

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EU Declaration of Conformity

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