AI Act

With its AI regulation, the EU is pursuing a risk-based approach to regulate AI technologies. For this purpose, four risk categories are defined, for which specific information obligations or prohibitions may apply. In the event of violations, the authorities of the member states may impose fines of up to 7% of the worldwide prior year’s turnover.

Inhaltsverzeichnis

CHAPTER I
GENERAL PROVISIONS

Art. 1 Subject matter
Art. 2 Scope
Art. 3 Definitions
Art. 4 AI literacy

CHAPTER II
PROHIBITED AI PRACTICES

Art. 5 Prohibited AI practices

CHAPTER III
HIGH-RISK AI SYSTEMS

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

Art. 8 Compliance with the requirements
Art. 9 Risk management system
Art. 10 Data and data governance
Art. 11 Technical documentation
Art. 12 Record-keeping
Art. 13 Transparency and provision of information to deployers
Art. 14 Human oversight
Art. 15 Accuracy, robustness and cybersecurity

SECTION 3
Obligations of providers and deployers of high-risk AI systems and other parties

Art. 16 Obligations of providers of high-risk AI systems
Art. 17 Quality management system
Art. 18 Documentation keeping
Art. 19 Automatically generated logs
Art. 20 Corrective actions and duty of information
Art. 21 Cooperation with competent authorities
Art. 22 Authorised representatives of providers of high-risk AI systems
Art. 23 Obligations of importers
Art. 24 Obligations of distributors
Art. 25 Responsibilities along the AI value chain
Art. 26 Obligations of deployers of high-risk AI systems
Art. 27 Fundamental rights impact assessment for high-risk AI systems

SECTION 4
Notifying authorities and notified bodies

Art. 28 Notifying authorities
Art. 29 Application of a conformity assessment body for notification
Art. 30 Notification procedure
Art. 31 Requirements relating to notified bodies
Art. 32 Presumption of conformity with requirements relating to notified bodies
Art. 33 Subsidiaries of notified bodies and subcontracting
Art. 34 Operational obligations of notified bodies
Art. 35 Identification numbers and lists of notified bodies
Art. 36 Changes to notifications
Art. 37 Challenge to the competence of notified bodies
Art. 38 Coordination of notified bodies
Art. 39 Conformity assessment bodies of third countries

SECTION 5
Standards, conformity assessment, certificates, registration

Art. 40 Harmonised standards and standardisation deliverables
Art. 41 Common specifications
Art. 42 Presumption of conformity with certain requirements
Art. 43 Conformity assessment
Art. 44 Certificates
Art. 45 Information obligations of notified bodies
Art. 46 Derogation from conformity assessment procedure
Art. 47 EU declaration of conformity
Art. 48 CE marking
Art. 49 Registration

CHAPTER IV
TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN AI SYSTEMS

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

CHAPTER V
GENERAL-PURPOSE AI MODELS

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

CHAPTER VI
MEASURES IN SUPPORT OF INNOVATION

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. 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

CHAPTER VII
GOVERNANCE

SECTION 1
Governance at Union level

Art. 64 AI Office
Art. 65 Establishment and structure of the European Artificial Intelligence Board
Art. 66 Tasks of the Board
Art. 67 Advisory forum
Art. 68 Scientific panel of independent experts
Art. 69 Access to the pool of experts by the Member States

SECTION 2
National competent authorities

Art. 70 Designation of national competent authorities and single points of contact

CHAPTER VIII
EU DATABASE FOR HIGH-RISK AI SYSTEMS

Art. 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

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

Art. 74 Market surveillance and control of AI systems in the Union market
Art. 75 Mutual assistance, market surveillance and control of general-purpose AI systems
Art. 76 Supervision of testing in real world conditions by market surveillance authorities
Art. 77 Powers of authorities protecting fundamental rights
Art. 78 Confidentiality
Art. 79 Procedure at national level for dealing with AI systems presenting a risk
Art. 80 Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III
Art. 81 Union safeguard procedure
Art. 82 Compliant AI systems which present a risk
Art. 83 Formal non-compliance
Art. 84 Union AI testing support structures

SECTION 4
Remedies

Art. 85 Right to lodge a complaint with a market surveillance authority
Art. 86 Right to explanation of individual decision-making
Art. 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

Art. 88 Enforcement of the obligations of providers of general-purpose AI models
Art. 89 Monitoring actions
Art. 90 Alerts of systemic risks by the scientific panel
Art. 91 Power to request documentation and information
Art. 92 Power to conduct evaluations
Art. 93 Power to request measures
Art. 94 Procedural rights of economic operators of the general-purpose AI model

CHAPTER X
CODES OF CONDUCT AND GUIDELINES

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

CHAPTER XI
DELEGATION OF POWER AND COMMITTEE PROCEDURE

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

CHAPTER XII
PENALTIES

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

CHAPTER XIII
FINAL PROVISIONS

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
ANNEXES

ANNEX I
List of 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

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

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

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

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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