EU-AI-Act
Regulation (EU) 2024/1689 — Artificial Intelligence Act
- I. General Provisions
- Art. 1. Subject matter ref
- Art. 2. Scope ref
- Art. 3. Definitions ref
- Art. 4. AI literacy ref
- II. Prohibited AI Practices
- Art. 5. Prohibited artificial intelligence practices ref
- III. High-Risk AI Systems
- Ch. 1 — Classification of AI Systems as High-Risk
- Art. 6. Classification rules for high-risk AI systems (7)
- Art. 7. Amendments to Annex III (12)
- Ch. 2 — Requirements for High-Risk AI Systems
- Art. 8. Compliance with the requirements (5)
- Art. 9. Risk management system (15)
- Art. 10. Data and data governance (20)
- Art. 11. Technical documentation (7)
- Art. 12. Record-keeping (8)
- Art. 13. Transparency and provision of information to deployers (14)
- Art. 14. Human oversight (11)
- Art. 15. Accuracy, robustness and cybersecurity (9)
- Ch. 3 — Obligations of Providers and Deployers of High-Risk AI Systems and Other Parties
- Art. 16. Obligations of providers of high-risk AI systems (12)
- Art. 17. Quality management system (16)
- Art. 18. Documentation keeping (6)
- Art. 19. Automatically generated logs (2)
- Art. 20. Corrective actions and duty of information (5)
- Art. 21. Cooperation with competent authorities (3)
- Art. 22. Duty of providers of high-risk AI systems to inform (2)
- Art. 23. Obligations of importers (12)
- Art. 24. Obligations of distributors (10)
- Art. 25. Responsibilities along the AI value chain (9)
- Ch. 4 — Obligations of Deployers of High-Risk AI Systems
- Art. 26. Obligations of deployers of high-risk AI systems (17)
- Art. 27. Fundamental rights impact assessment for high-risk AI systems (10)
- Ch. 5 — Notifying Authorities and Notified Bodies
- Art. 28. Notifying authorities (8)
- IV. Transparency Obligations for Providers and Deployers of Certain AI Systems
- Art. 50. Transparency obligations for providers and deployers of certain AI systems (9)
- V. General-Purpose AI Models
- Ch. 1 — Classification Rules
- Art. 51. Classification of general-purpose AI models as general-purpose AI models with systemic risk (4)
- Ch. 2 — Obligations for Providers of General-Purpose AI Models
- Art. 53. Obligations for providers of general-purpose AI models (6)
- Art. 54. Authorised representatives of providers of general-purpose AI models (11)
- Art. 55. Obligations for providers of general-purpose AI models with systemic risk (6)
- Art. 56. Codes of practice (8)
- VIII. Post-Market Monitoring, Information Sharing and Market Surveillance
- Ch. 1 — Post-Market Monitoring
- Art. 72. Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems (7)
- Ch. 2 — Sharing of Information on Serious Incidents
- Art. 73. Reporting of serious incidents (12)
- X. Codes of Conduct and Guidelines
- Art. 95. Codes of conduct for voluntary application of specific requirements (6)
- XII. Penalties
- Art. 99. Penalties (8)
- Art. 100. Administrative fines on Union institutions, bodies, offices and agencies (7)
- Art. 101. Penalties for providers of general-purpose AI models (4)
- Annex I. Union Harmonisation Legislation Listed in Article 6(1)
- Annex III. High-Risk AI Systems Referred to in Article 6(2)
- Annex IV. Technical Documentation Referred to in Article 11(1)
Title I — General Provisions
Title II — Prohibited AI Practices
Title III — High-Risk AI Systems
Chapter 1 — Classification of AI Systems as High-Risk
Article 7. Amendments to Annex III
6 obligations
EU-AIA-7-07
Requirement
Assess potential harm extent criterion when amending Annex III
The Commission must take into account the potential extent of harm or adverse impact, particularly in terms of intensity
EU-AIA-7-08
Requirement
Assess dependency on AI outcome criterion when amending Annex III
The Commission must take into account the extent to which potentially harmed persons are dependent on the AI system outc
EU-AIA-7-09
Requirement
Assess power imbalance criterion when amending Annex III
The Commission must take into account the extent of power imbalance or vulnerability of potentially harmed persons in re
EU-AIA-7-10
Requirement
Assess outcome reversibility criterion when amending Annex III
The Commission must take into account the extent to which AI system outcomes are easily corrigible or reversible, consid
EU-AIA-7-11
Requirement
Assess deployment benefits criterion when amending Annex III
The Commission must take into account the magnitude and likelihood of benefit of AI system deployment for individuals, g
EU-AIA-7-12
Requirement
Assess existing legal redress criterion when amending Annex III
The Commission must take into account the extent to which existing Union law provides for effective measures of redress
Chapter 2 — Requirements for High-Risk AI Systems
Chapter 3 — Obligations of Providers and Deployers of High-Risk AI Systems and Other Parties
Chapter 4 — Obligations of Deployers of High-Risk AI Systems
Chapter 5 — Notifying Authorities and Notified Bodies
Title IV — Transparency Obligations for Providers and Deployers of Certain AI Systems
Title V — General-Purpose AI Models
Chapter 1 — Classification Rules
Chapter 2 — Obligations for Providers of General-Purpose AI Models
Title VIII — Post-Market Monitoring, Information Sharing and Market Surveillance
Chapter 1 — Post-Market Monitoring
Article 72. Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems
7 obligations
EU-AIA-72-01
Monitoring
Establish and document post-market monitoring system
Providers must establish and document a post-market monitoring system that is proportionate to the nature of the AI tech
EU-AIA-72-02
Data Governance
Actively collect, document and analyse performance data
The post-market monitoring system must actively and systematically collect, document and analyse relevant data on the pe
EU-AIA-72-03
Conformity
Evaluate continuous compliance with Chapter 2 requirements
Providers must use the collected data to evaluate the continuous compliance of AI systems with the requirements set out
EU-AIA-72-04
Monitoring
Include analysis of AI system interactions where relevant
Where relevant, post-market monitoring must include an analysis of the interaction with other AI systems.
EU-AIA-72-05
Documentation
Base monitoring system on post-market monitoring plan
The post-market monitoring system must be based on a post-market monitoring plan.
EU-AIA-72-06
Documentation
Include monitoring plan in technical documentation
The post-market monitoring plan must be part of the technical documentation referred to in Annex IV.
EU-AIA-72-07
Monitoring
Integrate monitoring elements into existing Union harmonisation systems
For high-risk AI systems covered by Union harmonisation legislation listed in Section A of Annex I, providers must integ
Chapter 2 — Sharing of Information on Serious Incidents
Article 73. Reporting of serious incidents
12 obligations
EU-AIA-73-01
Reporting
Report serious incidents to market surveillance authorities
Providers must report any serious incident to the market surveillance authorities of the Member States where the inciden
EU-AIA-73-02
Reporting
Report serious incidents within 15 days after establishing causal link
The report must be made immediately after establishing a causal link (or reasonable likelihood) between the AI system an
EU-AIA-73-03
Reporting
Report widespread infringement or serious incidents within 2 days
For widespread infringement or serious incidents as defined in Article 3, point (44)(c), the report must be provided imm
EU-AIA-73-04
Reporting
Report death-related incidents within 10 days
In the event of death of a person, the report must be made immediately after establishing or suspecting a causal relatio
EU-AIA-73-05
Reporting
Submit initial incomplete report when necessary for timely reporting
Where necessary to ensure timely reporting, an initial incomplete report may be submitted, followed by a complete report
EU-AIA-73-06
Risk Management
Perform necessary investigations after reporting serious incident
Following the reporting of a serious incident, the provider must perform without delay the necessary investigations in r
EU-AIA-73-07
Prohibition
Prohibit alteration of AI system during investigation without authority notification
The provider must not perform any investigation in a manner that involves altering the AI system in a way which may affe
EU-AIA-73-08
Reporting
Market surveillance authority must inform national public authorities of specific incidents
Upon receiving notification of a serious incident referred to in Article 3, point (44)(c), the relevant market surveilla
EU-AIA-73-09
Requirement
Market surveillance authority must take appropriate measures within seven days
The market surveillance authority shall take appropriate measures as provided for in Article 19 of Regulation (EU) 2019/
EU-AIA-73-10
Reporting
Limited notification for systems with equivalent reporting obligations
For high-risk AI systems in Annex III placed on market by providers subject to Union legislative instruments with equiva
EU-AIA-73-11
Reporting
Limited notification for medical device AI systems
For high-risk AI systems that are safety components of devices or are themselves devices covered by Regulations (EU) 201
EU-AIA-73-12
Requirement
National authorities must take immediate measures and transmit notifications
Competent national public authorities or bodies referred to in Article 77(1) shall immediately take necessary measures w