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Contents

I General provisions

Chapter overview
Art. 1 Subject matter
Art. 2 Scope
Art. 3 Definitions
Art. 4 AI literacy
Art. 4a Processing of special categories of personal data for bias detection and correction

II Prohibited AI practices

Chapter overview
Art. 5 Prohibited AI practices

III High-risk AI systems

Chapter overview
Section 1 · Classification of AI systems as high-risk
- Art. 6 Classification rules for high-risk AI systems
- Art. 7 Amendments to Annex III
Section 2 · Requirements for high-risk AI systems
Section 3 · Obligations of providers and deployers of high-risk AI systems and other parties
Section 4 · Notifying authorities and notified bodies
Section 5 · Standards, conformity assessment, certificates, registration

IV Transparency obligations for certain AI systems

Chapter overview
Art. 50 Transparency obligations for providers and deployers of certain AI systems

V General-purpose AI models

Chapter overview
Section 1 · Classification rules
- Art. 51 Classification of general-purpose AI models as general-purpose AI models with systemic risk
- Art. 52 Procedure
Section 2 · Obligations for providers of general-purpose AI models
- Art. 53 Obligations for providers of general-purpose AI models
- Art. 54 Authorised representatives of providers of general-purpose AI models
Section 3 · Obligations of providers of general-purpose AI models with systemic risk
- Art. 55 Obligations of providers of general-purpose AI models with systemic risk
Section 4 · Codes of practice
- Art. 56 Codes of practice

VI Measures in support of innovation

Chapter overview
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. 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
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

VII Governance

Chapter overview
Section 1 · Governance at Union level
Section 2 · National competent authorities
- Art. 70 Designation of national competent authorities and single points of contact

VIII EU database for high-risk AI systems

Chapter overview
Art. 71 EU database for high-risk AI systems listed in Annex III

IX Post-market monitoring, information sharing and market surveillance

Chapter overview
Section 1 · Post-market monitoring
- Art. 72 Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems
Section 2 · Sharing of information on serious incidents
- Art. 73 Reporting of serious incidents
Section 3 · Enforcement
Section 4 · Remedies
Section 5 · Supervision, investigation, enforcement and monitoring in respect of providers of general-purpose AI models

X Codes of conduct and guidelines

Chapter overview
Art. 95 Codes of conduct for voluntary application of specific requirements
Art. 96 Guidelines from the Commission on the implementation of this Regulation

XI Delegation of power and committee procedure

Chapter overview
Art. 97 Exercise of the delegation
Art. 98 Committee procedure

XII Penalties

Chapter overview
Art. 99 Penalties
Art. 100 Administrative fines on Union institutions, bodies, offices and agencies
Art. 101 Fines for providers of general-purpose AI models

XIII Final provisions

Chapter overview
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

AAnnexes I–XIV

I List of Union harmonisation legislation
II List of criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii)
III High-risk AI systems referred to in Article 6(2)
IV Technical documentation referred to in Article 11(1)
V EU declaration of conformity
VI Conformity assessment procedure based on internal control
VII Conformity based on an assessment of the quality management system and an assessment of the technical documentation
VIII Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49
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
X Union legislative acts on large-scale IT systems in the area of Freedom, Security and Justice
XI Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models
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
XIII Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51
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

RRecitals 1–180

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180

AI Act / Chapter III / Section 2

Section 2

Requirements for high-risk AI systems

8 articles

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

← Previous · Article 7 Amendments to Annex III Next · Article 8 → Compliance with the requirements

Refers to this section

Art. 3 Art. 59 Art. 66 Art. 72 Art. 74 Art. 79 Art. 80 Art. 95 Art. 102 Art. 103 Art. 104 Art. 105 +8 more

Which articles apply to your system? The free risk assessment maps your system to its Annex III tier and obligations. No signup. Start free risk assessment

Cite

Regulation (EU) 2024/1689, Section 2

←Article 7 Search →Article 8

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