Artificial Intelligence Act

Art. 1

Subject matter`

Art. 2

Scope

Art. 3

Definitions

Art. 4

AI literacy

Art. 5

Prohibited AI practices

Art. 6

Classification rules for high-risk AI systems

Art. 7

Amendments to Annex III

Art. 8

Compliance with the requirements

Art. 9

Risk management system

Art. 10

Data and data governance

Art. 11

Technical documentation

Art. 12

Record-keeping

Art. 13

Transparency and provision of information to deployers

Art. 14

Human oversight

Art. 15

Accuracy, robustness and cybersecurity

Art. 16

Obligations of providers of high-risk AI systems

Art. 17

Quality management system

Art. 18

Documentation keeping

Art. 19

Automatically generated logs

Art. 20

Corrective actions and duty of information

Art. 21

Cooperation with competent authorities

Art. 22

Authorised representatives of providers of high-risk AI systems

Art. 23

Obligations of importers

Art. 24

Obligations of distributors

Art. 25

Responsibilities along the AI value chain

Art. 26

Obligations of deployers of high-risk AI systems

Art. 27

Fundamental rights impact assessment for high-risk AI systems

Art. 28

Notifying authorities

Art. 29

Application of a conformity assessment body for notification

Art. 30

Notification procedure

Art. 31

Requirements relating to notified bodies

Art. 32

Presumption of conformity with requirements relating to notified bodies

Art. 33

Subsidiaries of notified bodies and subcontracting

Art. 34

Operational obligations of notified bodies

Art. 35

Identification numbers and lists of notified bodies

Art. 36

Changes to notifications

Art. 37

Challenge to the competence of notified bodies

Art. 38

Coordination of notified bodies

Art. 39

Conformity assessment bodies of third countries

Art. 40

Harmonised standards and standardisation deliverables

Art. 41

Common specifications

Art. 42

Presumption of conformity with certain requirements

Art. 43

Conformity assessment

Art. 44

Certificates

Art. 45

Information obligations of notified bodies

Art. 46

Derogation from conformity assessment procedure

Art. 47

EU declaration of conformity

Art. 48

CE marking

Art. 49

Registration

Art. 50

Transparency obligations for providers and deployers of certain AI systems

Art. 51

Classification of general-purpose AI models as general-purpose AI models with systemic risk

Art. 52

Procedure

Art. 53

Obligations for providers of general-purpose AI models

Art. 54

Authorised representatives of providers of general-purpose AI models

Art. 55

Obligations of providers of general-purpose AI models with systemic risk

Art. 56

Codes of practice

Art. 57

AI regulatory sandboxes

Art. 58

Detailed arrangements for, and functioning of, AI regulatory sandboxes

Art. 59

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

Art. 60

Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes

Art. 61

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

Art. 62

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

Art. 63

Derogations for specific operators

Art. 64

AI Office

Art. 65

Establishment and structure of the European Artificial Intelligence Board

Art. 66

Tasks of the Board

Art. 67

Advisory forum

Art. 68

Scientific panel of independent experts

Art. 69

Access to the pool of experts by the Member States

Art. 70

Designation of national competent authorities and single points of contact

Art. 71

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

Art. 72

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

Art. 73

Reporting of serious incidents

Art. 74

Market surveillance and control of AI systems in the Union market

Art. 75

Mutual assistance, market surveillance and control of general-purpose AI systems

Art. 76

Supervision of testing in real world conditions by market surveillance authorities

Art. 77

Powers of authorities protecting fundamental rights

Art. 78

Confidentiality

Art. 79

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

Art. 80

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

Art. 81

Union safeguard procedure

Art. 82

Compliant AI systems which present a risk

Art. 83

Formal non-compliance

Art. 84

Union AI testing support structures

Art. 85

Right to lodge a complaint with a market surveillance authority

Art. 86

Right to explanation of individual decision-making

Art. 87

Reporting of infringements and protection of reporting persons

Art. 88

Enforcement of the obligations of providers of general-purpose AI models

Art. 89

Monitoring actions

Art. 90

Alerts of systemic risks by the scientific panel

Art. 91

Power to request documentation and information

Art. 92

Power to conduct evaluations

Art. 93

Power to request measures

Art. 94

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

Art. 95

Codes of conduct for voluntary application of specific requirements

Art. 96

Guidelines from the Commission on the implementation of this Regulation

Art. 97

Exercise of the delegation

Art. 98

Committee procedure

Art. 99

Penalties

Art. 100

Administrative fines on Union institutions, bodies, offices and agencies

Art. 101

Fines for providers of general-purpose AI models

Art. 102

Amendment to Regulation (EC) No 300/2008

Art. 103

Amendment to Regulation (EU) No 167/2013

Art. 104

Amendment to Regulation (EU) No 168/2013

Art. 105

Amendment to Directive 2014/90/EU

Art. 106

Amendment to Directive (EU) 2016/797

Art. 107

Amendment to Regulation (EU) 2018/858

Art. 108

Amendments to Regulation (EU) 2018/1139

Art. 109

Amendment to Regulation (EU) 2019/2144

Art. 110

Amendment to Directive (EU) 2020/1828

Art. 111

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

Art. 112

Evaluation and review

Art. 113

Entry into force and application