Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 Jun... (32024R1689)
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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 (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)
- CHAPTER I
- GENERAL PROVISIONS
- Article 1
- Subject matter`
- Article 2
- Scope
- Article 3
- Definitions
- Article 4
- AI literacy
- CHAPTER II
- PROHIBITED AI PRACTICES
- Article 5
- Prohibited AI practices
- CHAPTER III
- HIGH-RISK AI SYSTEMS
- 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
- Article 50
- Transparency obligations for providers and deployers of certain AI systems
- CHAPTER V
- GENERAL-PURPOSE AI MODELS
- 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
- 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
- CHAPTER VII
- GOVERNANCE
- 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
- Article 71
- EU database for high-risk AI systems listed in Annex III
- CHAPTER IX
- POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE
- 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
- Mutual assistance, market surveillance and control of general-purpose AI systems
- Article 76
- Supervision of testing in real world conditions by market surveillance authorities
- Article 77
- Powers of authorities protecting fundamental rights
- 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
- 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
- Article 97
- Exercise of the delegation
- Article 98
- Committee procedure
- CHAPTER XII
- PENALTIES
- 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
- 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
- ANNEX I
- List of Union harmonisation legislation
- Section A. List of Union harmonisation legislation based on the New Legislative Framework
- Section B. List of other 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
- 1. Introduction
- 2. Overview
- 3. Quality management system
- 4. Control of the technical documentation.
- 5. Surveillance of the approved quality management system.
- 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)
- Section C — Information to be submitted by deployers of high-risk AI systems in accordance with Article 49(3)
- 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
- 1. Schengen Information System
- 2. Visa Information System
- 3. Eurodac
- 4. Entry/Exit System
- 5. European Travel Information and Authorisation System
- 6. European Criminal Records Information System on third-country nationals and stateless persons
- 7. Interoperability
- ANNEX XI
- 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
- Section 2
- Additional information to be provided by providers of general-purpose AI models with systemic risk
- 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
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