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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 12 AI Act

Article 12 AI Act

In force

❌ 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 2. Requirements for high-risk AI systems

Article 12. Record-keeping

  1. High-risk AI systems shall technically allow for the automatic recording of events (logs) over the lifetime of the system.
  1. In order to ensure a level of traceability of the functioning of a high-risk AI system that is appropriate to the intended purpose of the system, logging capabilities shall enable the recording of events relevant for:
  1. identifying situations that may result in the high-risk AI system presenting a risk within the meaning of Article 79(1) or in a substantial modification;
  1. facilitating the post-market monitoring referred to in Article 72; and
  1. monitoring the operation of high-risk AI systems referred to in Article 26(5).
  1. For high-risk AI systems referred to in point 1 (a), of Annex III, the logging capabilities shall provide, at a minimum:
  1. recording of the period of each use of the system (start date and time and end date and time of each use);
  1. the reference database against which input data has been checked by the system;
  1. input data for which the search has led to a match;
  1. the identification of the natural persons involved in the verification of the results, as referred to in Article 14(5).

Notes

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