AI Act — REGULATION (EU) 2024/1689 OF THE EUROPEAN PARLIAMENT AND OF…

AI Act — REGULATION (EU) 2024/1689 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 June 2024 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) (Text with EEA relevance)

regulation · European Union · 32024R1689

1437 provisions in 1760 nodes · cited by 4 instruments we hold · 27 provisions hand work to national law

Defined terms · All instruments · artificial intelligence · harmonisation of standards · innovation · market approval · new technology · single market · smart technology

Table

REGULATION (EU) 2024/1689 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 13 June 2024

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)

(Text with EEA relevance)

Article 1 Subject matter`

Article 3 Definitions

Article 4 AI literacy

Subparagraph

Article 5 Prohibited AI practices

Article 6 Classification rules for high-risk AI systems

Article 7 Amendments to Annex III

Article 8 Compliance with the requirements

Subparagraph

Article 9 Risk management system

Article 10 Data and data governance

Article 11 Technical documentation

Subparagraph

Article 12 Record-keeping

Article 13 Transparency and provision of information to deployers

Article 14 Human oversight

Article 15 Accuracy, robustness and cybersecurity

Subparagraph

Article 16 Obligations of providers of high-risk AI systems

Article 17 Quality management system

Article 18 Documentation keeping

Article 19 Automatically generated logs

Subparagraph

Article 20 Corrective actions and duty of information

Subparagraph

Article 21 Cooperation with competent authorities

Subparagraph

Article 22 Authorised representatives of providers of high-risk AI systems

Article 23 Obligations of importers

Article 24 Obligations of distributors

Subparagraph

Article 25 Responsibilities along the AI value chain

Article 26 Obligations of deployers of high-risk AI systems

Subparagraph

Article 27 Fundamental rights impact assessment for high-risk AI systems

Article 28 Notifying authorities

Subparagraph

Article 29 Application of a conformity assessment body for notification

Subparagraph

Article 30 Notification procedure

Subparagraph

Article 31 Requirements relating to notified bodies

Subparagraph

Article 32 Presumption of conformity with requirements relating to notified bodies

Subparagraph

Article 33 Subsidiaries of notified bodies and subcontracting

Subparagraph

Article 34 Operational obligations of notified bodies

Subparagraph

Article 35 Identification numbers and lists of notified bodies

Subparagraph

Article 36 Changes to notifications

Article 37 Challenge to the competence of notified bodies

Subparagraph

Article 38 Coordination of notified bodies

Subparagraph

Article 39 Conformity assessment bodies of third countries

Subparagraph

Article 40 Harmonised standards and standardisation deliverables

Subparagraph

Article 41 Common specifications

Article 42 Presumption of conformity with certain requirements

Subparagraph

Article 43 Conformity assessment

Article 44 Certificates

Subparagraph

Article 45 Information obligations of notified bodies

Article 46 Derogation from conformity assessment procedure

Subparagraph

Article 47 EU declaration of conformity

Subparagraph

Article 48 CE marking

Subparagraph

Article 49 Registration

Article 50 Transparency obligations for providers and deployers of certain AI systems

Subparagraph

Article 51 Classification of general-purpose AI models as general-purpose AI models with systemic risk

Article 53 Obligations for providers of general-purpose AI models

Article 54 Authorised representatives of providers of general-purpose AI models

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

Article 56 Codes of practice

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 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

Subparagraph

Article 64 AI Office

Subparagraph

Article 65 Establishment and structure of the European Artificial Intelligence Board

Article 66 Tasks of the Board

Article 67 Advisory forum

Subparagraph

Article 68 Scientific panel of independent experts

Article 69 Access to the pool of experts by the Member States

Subparagraph

Article 70 Designation of national competent authorities and single points of contact

Subparagraph

Article 71 EU database for high-risk AI systems listed in Annex III

Subparagraph

Article 72 Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems

Subparagraph

Article 73 Reporting of serious incidents

Subparagraph

Article 74 Market surveillance and control of AI systems in the Union market

Article 75 Mutual assistance, market surveillance and control of general-purpose AI systems

Subparagraph

Article 76 Supervision of testing in real world conditions by market surveillance authorities

Article 77 Powers of authorities protecting fundamental rights

Subparagraph

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

Subparagraph

Article 81 Union safeguard procedure

Subparagraph

Article 82 Compliant AI systems which present a risk

Subparagraph

Article 83 Formal non-compliance

Article 84 Union AI testing support structures

Subparagraph

Article 85 Right to lodge a complaint with a market surveillance authority

Subparagraph

Article 86 Right to explanation of individual decision-making

Subparagraph

Article 87 Reporting of infringements and protection of reporting persons

Subparagraph

Article 88 Enforcement of the obligations of providers of general-purpose AI models

Subparagraph

Article 89 Monitoring actions

Article 90 Alerts of systemic risks by the scientific panel

Article 91 Power to request documentation and information

Subparagraph

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

Subparagraph

Article 95 Codes of conduct for voluntary application of specific requirements

Article 96 Guidelines from the Commission on the implementation of this Regulation

Article 97 Exercise of the delegation

Subparagraph

Article 98 Committee procedure

Article 100 Administrative fines on Union institutions, bodies, offices and agencies

Article 101 Fines for providers of general-purpose AI models

Article 102 Amendment to Regulation (EC) No 300/2008

Subparagraph

Article 103 Amendment to Regulation (EU) No 167/2013

Subparagraph

Article 104 Amendment to Regulation (EU) No 168/2013

Subparagraph

Article 105 Amendment to Directive 2014/90/EU

Subparagraph

Article 106 Amendment to Directive (EU) 2016/797

Subparagraph

Article 107 Amendment to Regulation (EU) 2018/858

Subparagraph

Article 108 Amendments to Regulation (EU) 2018/1139

Article 109 Amendment to Regulation (EU) 2019/2144

Subparagraph

Article 110 Amendment to Directive (EU) 2020/1828

Subparagraph

‘(68)

Article 111 AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked

Subparagraph

Article 112 Evaluation and review

Article 113 Entry into force and application

List of Union harmonisation legislation

Section A. List of Union harmonisation legislation based on the New Legislative Framework

Table

Section B. List of other Union harmonisation legislation

Table

ANNEX II

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

Subparagraph

—

ANNEX III

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

Technical documentation referred to in Article 11(1)

EU declaration of conformity

Subparagraph

ANNEX VI

Conformity assessment procedure based on internal control

Subparagraph

ANNEX VII

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

3. Quality management system

Table

4. Control of the technical documentation.

Table

5. Surveillance of the approved quality management system.

Table

ANNEX VIII

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

Section A — Information to be submitted by providers of high-risk AI systems in accordance with Article 49(1)

Section B — Information to be submitted by providers of high-risk AI systems in accordance with Article 49(2)

Subparagraph

Section C — Information to be submitted by deployers of high-risk AI systems in accordance with Article 49(3)

Subparagraph

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

Subparagraph

ANNEX X

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

1. Schengen Information System

(a)

(b)

(c)

2. Visa Information System

5. European Travel Information and Authorisation System

(a)

(b)

6. European Criminal Records Information System on third-country nationals and stateless persons

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

Section 1

Information to be provided by all providers of general-purpose AI models

Additional information to be provided by providers of general-purpose AI models with systemic risk

Table

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

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