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Digital Services Act
Data Governance Act
Artificial Intelligence Act
Platform-to-Business Regulation

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Content:

Article 1 - Subject matter
Article 2 - Scope
Article 3 - Definitions
Article 4 - AI literacy

Article 5 - Prohibited AI Practices

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

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

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

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

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

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

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

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

Further information:

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)

Date: 02.08.2024 ()
EUR-Lex CELEX: 32024R1689 🔗
Tags: ai

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