EU Artificial Intelligence Act

EU Artificial Intelligence Act

Table of Contents

Articles

Article 1 – Subject matter

Article 2 – Scope

Article 3 – Definitions

Article 4 – AI literacy

Article 5 – Prohibited artificial intelligence practices

Article 6 – Classification rules for high-risk AI systems

Article 7 – Amendments to Annex III

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 users

Article 14 – Human oversight

Article 15 – Accuracy, robustness and cybersecurity

Article 16 – Obligations of providers of high-risk AI systems

Article 17 – Quality management system

Article 18 – Obligation to draw up technical documentation

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 26 – Obligations of deployers of high-risk AI systems

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

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

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 – Appeal against decisions of notified bodies

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

Article 50 – Transparency obligations for certain AI systems

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

Article 52 – Procedure

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

Article 64 – AI Office

Article 65 – Establishment 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

Article 70 – Designation of national competent authorities

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

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

Article 73 – Reporting of serious incidents

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 presenting a risk at national level

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

Article 84 – Union AI testing support structures

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

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

Article 86 – Right to explanation of individual decision-making

Article 86 – Right to explanation of individual decision-making

Article 87 – Reporting of infringements and protection of reporting persons

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

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

Article 98 – Committee procedure

Article 99 – Penalties

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

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

FINAL PROVISIONS

ANNEX I – ARTIFICIAL INTELLIGENCE TECHNIQUES AND APPROACHES

ANNEX II – LIST OF UNION HARMONISATION LEGISLATION

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 ASSESSMENT OF QUALITY MANAGEMENT SYSTEM AND ASSESSMENT OF TECHNICAL DOCUMENTATION

ANNEX VIII – INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF HIGH-RISK AI SYSTEMS IN ACCORDANCE WITH ARTICLE 51

ANNEX IX – Union legislation ON large-scale IT systems in the area of Freedom, Security and Justice

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)

ANNEX XII – Transparency information referred to in Article 53(1), point (b)

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

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