AI Act

Regulation (EU) 2024/1689 of the European Parliament and of the Council laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) – Official Journal

As amended by:
Regulation (EU) 2026/1744 of the European Parliament and of the Council of 8 July 2026 amending Regulations (EU) 2024/1689, (EU) 2018/1139 and (EU) 2023/1230 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI) – Official Journal

Provided by: reuschlaw

Table of contents

• Chapter I

    -  

  General Provisions (Art. 1 - 4)
• Article 1

    -  

  Subject matter
• Article 2

    -  

  Scope
• Article 3

    -  

  Definitions
• Article 4

    -  

  AI literacy
• Article 4a

    -  

  Processing of special categories of personal data for bias detection and correction

• Chapter II

    -  

  Prohibited AI practices (Art. 5)
• Article 5

    -  

  Prohibited AI practices

• Chapter III

    -  

  High-risk AI systems (Art. 6 - 49)
• Section 1

    -  

  Classification of AI systems as high-risk
• Article 6

    -  

  Classification rules for high-risk AI systems
• Article 7

    -  

  Amendments to Annex III
• 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

• Chapter IV

    -  

  Transparency obligations for providers and deployers of certain AI systems (Art. 50)
• Article 50

    -  

  Transparency obligations for providers and deployers of certain AI systems

• Chapter V

    -  

  General-purpose AI models (Art. 51 - 56)
• Section 1

    -  

  Classification rules
• Article 51

    -  

  Classification of general-purpose AI models as general-purpose AI models with systemic risk
• Article 52

    -  

  Procedure
• Section 2

    -  

  Obligations for providers of general-purpose AI models
• Article 53

    -  

  Obligations for providers of general-purpose AI models
• Article 54

    -  

  Authorised representatives of providers of general-purpose AI models
• Section 3

    -  

  Obligations of providers of general-purpose AI models with systemic risk
• Article 55

    -  

  Obligations of providers of general-purpose AI models with systemic risk
• Section 4

    -  

  Codes of practice
• Article 56

    -  

  Codes of practice

• Chapter VI

    -  

  Measures in support of innovation (Art. 57 - 63)
• Article 57

    -  

  AI regulatory sandboxes
• Article 58

    -  

  Detailed arrangements for, and functioning of, AI regulatory sandboxes
• Article 59

    -  

  Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox
• Article 60

    -  

  Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes
• Article 60a

    -  

  Testing of high-risk AI systems covered by Union harmonisation legislation listed in Section B of Annex I in real-world conditions outside AI regulatory sandboxes
• Article 61

    -  

  Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes
• Article 62

    -  

  Measures for providers and deployers, in particular SMEs, including start-ups
• Article 63

    -  

  Derogations for specific operators

• Chapter VII

    -  

  Governance (Art. 64 - 70)
• Section 1

    -  

  Governance at Union level
• Article 64

    -  

  AI Office
• Article 65

    -  

  Establishment and structure of the European Artificial Intelligence Board
• Article 66

    -  

  Tasks of the Board
• Article 67

    -  

  Advisory forum
• Article 68

    -  

  Scientific panel of independent experts
• Article 69

    -  

  Access to the pool of experts by the Member States
• Section 2

    -  

  National competent authorities
• Article 70

    -  

  Designation of national competent authorities and single points of contact

• Chapter VIII

    -  

  EU database for high-risk AI systems (Art. 71)
• Article 71

    -  

  EU database for high-risk AI systems listed in Annex III

• Chapter IX

    -  

  Post-market monitoring, information sharing and market surveillance (Art. 72 - 94)
• Section 1

    -  

  Post-market monitoring
• Article 72

    -  

  Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems
• Section 2

    -  

  Sharing of information on serious incidents
• Article 73

    -  

  Reporting of serious incidents
• Section 3

    -  

  Enforcement
• Article 74

    -  

  Market surveillance and control of AI systems in the Union market
• Article 75

    -  

  Market surveillance and control of AI systems and mutual assistance
• Article 75a

    -  

  Supervisory and enforcement powers of the AI Office
• Article 75b

    -  

  Commitments
• Article 75c

    -  

  Non-compliance, fines and periodic penalty payments
• Article 75d

    -  

  Safeguards and further specification
• Article 76

    -  

  Supervision of testing in real world conditions by market surveillance authorities
• Article 77

    -  

  Powers of authorities protecting fundamental rights and cooperation with market surveillance authorities
• Article 78

    -  

  Confidentiality
• Article 79

    -  

  Procedure at national level for dealing with AI systems presenting a risk
• Article 80

    -  

  Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III
• Article 81

    -  

  Union safeguard procedure
• Article 82

    -  

  Compliant AI systems which present a risk
• Article 83

    -  

  Formal non-compliance
• Article 84

    -  

  Union AI testing support structures
• Section 4

    -  

  Remedies
• Article 85

    -  

  Right to lodge a complaint with a market surveillance authority
• Article 86

    -  

  Right to explanation of individual decision-making
• Article 87

    -  

  Reporting of infringements and protection of reporting persons
• Section 5

    -  

  Supervision, investigation, enforcement and monitoring in respect of providers of general-purpose AI models
• Article 88

    -  

  Enforcement of the obligations of providers of general-purpose AI models
• Article 89

    -  

  Monitoring actions
• Article 90

    -  

  Alerts of systemic risks by the scientific panel
• Article 91

    -  

  Power to request documentation and information
• Article 92

    -  

  Power to conduct evaluations
• Article 93

    -  

  Power to request measures
• Article 94

    -  

  Procedural rights of economic operators of the general-purpose AI model

• Chapter X

    -  

  Codes of conduct and guidelines (Art. 95 - 96)
• Article 95

    -  

  Codes of conduct for voluntary application of specific requirements
• Article 96

    -  

  Guidelines from the Commission on the implementation of this Regulation

• Chapter XI

    -  

  Delegation of power and committee procedure (Art. 97 - 98)
• Article 97

    -  

  Exercise of the delegation
• Article 98

    -  

  Committee procedure

• Chapter XII

    -  

  Penalties (Art. 99 - 101)
• Article 99

    -  

  Penalties
• Article 100

    -  

  Administrative fines on Union institutions, bodies, offices and agencies
• Article 101

    -  

  Fines for providers of general-purpose AI models

• Chapter XIII

    -  

  Final provisions (Art. 102 - 113)
• Article 102

    -  

  Amendment to Regulation (EC) No 300/2008
• Article 103

    -  

  Amendment to Regulation (EU) No 167/2013
• Article 104

    -  

  Amendment to Regulation (EU) No 168/2013
• Article 105

    -  

  Amendment to Directive 2014/90/EU
• Article 106

    -  

  Amendment to Directive (EU) 2016/797
• Article 107

    -  

  Amendment to Regulation (EU) 2018/858
• Article 108

    -  

  Amendments to Regulation (EU) 2018/1139
• Article 109

    -  

  Amendment to Regulation (EU) 2019/2144
• Article 110

    -  

  Amendment to Directive (EU) 2020/1828
• Article 111

    -  

  AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked
• Article 112

    -  

  Evaluation and review
• Article 113

    -  

  Entry into force and application

• Concluding formulas

Annexes

• Annex I

    -  

  List of Union harmonisation legislation
• Annex II

    -  

  List of criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii)
• Annex III

    -  

  High-risk AI systems referred to in Article 6(2)
• Annex IV

    -  

  Technical documentation referred to in Article 11(1)
• Annex V

    -  

  EU declaration of conformity
• Annex VI

    -  

  Conformity assessment procedure based on internal control
• Annex VII

    -  

  Conformity based on an assessment of the quality management system and an assessment of the technical documentation
• Annex VIII

    -  

  Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49
• Annex IX

    -  

  Information to be submitted upon the registration of high-risk AI systems listed in Annex III in relation to testing in real world conditions in accordance with Article 60
• Annex X

    -  

  Union legislative acts on large-scale IT systems in the area of Freedom, Security and Justice
• Annex XI

    -  

  Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models
• Annex XII

    -  

  Transparency information referred to in Article 53(1), point (b) — technical documentation for providers of general-purpose AI models to downstream providers that integrate the model into their AI system
• Annex XIII

    -  

  Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51
• Annex XIV

    -  

  The list of codes, categories and corresponding types of AI systems for the purpose of the notification procedure referred to in Article 30 specifying the scope of the designation as notified bodies