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Recitals

CHAPTER III. (Art. 6-49)

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 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

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

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

Article 45 AI Act

Article 45 AI Act

❌ In force from 1 August

❌ Applicable from 2 August 2026, ❌ with the exceptions of Article 6(1) and the corresponding obligations in this Regulation which apply from 2 August 2027 (See Art 113)

CHAPTER III. HIGH-RISK AI SYSTEMS

Section 5. Standards, conformity assessment, certificates, registration

Article 45. Information obligations of notified bodies

  1. Notified bodies shall inform the notifying authority of the following:
  1. any Union technical documentation assessment certificates, any supplements to those certificates, and any quality management system approvals issued in accordance with the requirements of Annex VII;
  1. any refusal, restriction, suspension or withdrawal of a Union technical documentation assessment certificate or a quality management system approval issued in accordance with the requirements of Annex VII;
  1. any circumstances affecting the scope of or conditions for notification;
  1. any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
  1. on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
  1. Each notified body shall inform the other notified bodies of:
  1. quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;
  1. Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.
  1. Each notified body shall provide the other notified bodies carrying out similar conformity assessment activities covering the same types of AI systems with relevant information on issues relating to negative and, on request, positive conformity assessment results.
  1. Notified bodies shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.

Notes

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