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Title I: General Provisions
Title IA: General Purpose AI Systems
Title II: Prohibited Artificial Intelligence Practices
Title III: Classification of AI Systems as High-Risk
Title IV: Transparency Obligations for Certain AI Systems
Title V: Measures in Support of Innovation
Title VI: Governance
Title VII: EU Database for Stand-Alone High-Risk AI Systems
Title VIII: Post-Market Monitoring, Information Sharing, Market Surveillance
Title IX: Codes of Conduct
Title X: Confidentiality and Penalties
Title XI: Delegation of Power and Committee Procedure
Title XII: Final Provisions
Chapter 1: Classification of AI Systems as High-Risk
Chapter 2: Requirements for High-Risk AI Systems
Chapter 3: Obligations of Providers and Users of High-Risk AI Systems and Other Parties
Chapter 4: Notifying Authorities and Notified Bodies
Chapter 5: Standards, Conformity Assessment, Certification, Registration
Chapter 1: European Artificial Intelligence Board
Chapter 1A: Guidelines From The Commission
Chapter 2: National Competent Authorities
Chapter 1: Post-Market Monitoring
Chapter 2: Sharing of Information on Incidents and Malfunctioning
Chapter 3: Enforcement
Art. 1 Subject Matter
Art. 2 Scope
Art. 3 Definitions
Art. 4 Implementing Acts
Art. 4a Compliance of General Purpose AI Systems with this Regulation
Art. 4b Requirements for General Purpose AI Systems and Obligations for Providers of such Systems
Art. 4c Exceptions to Article 4b
Art. 5 Prohibited Artificial Intelligence Practices
Art. 6 Classification Rules for High-Risk AI Systems
Art. 7 Amendments to Annex III
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 Users
Art. 14 Human Oversight
Art. 15 Accuracy, Robustness and Cybersecurity
Art. 16 Obligations of Providers of High-Risk AI Systems
Art. 17 Quality Management System
Art. 18 Documentation Keeping
Art. 19 Conformity Assessment
Art. 20 Automatically Generated Logs
Art. 21 Corrective Actions
Art. 22 Duty of Information
Art. 23 Cooperation with Competent Authorities
Art. 23a Conditions for Other Persons to be Subject to the Obligations of a Provider
Art. 24 [Deleted]
Art. 25 Authorised Representatives
Art. 26 Obligations of Importers
Art. 27 Obligations of Distributors
Art. 28 [Deleted]
Art. 29 Obligations of Users of High-Risk AI Systems
Art. 30 Notifying Authorities
Art. 31 Application of a Conformity Assessment Body for Notification
Art. 32 Notification Procedure
Art. 33 Requirements Relating to Notified Bodies
Art. 33a Presumption of Conformity with Requirements Relating to Notified Bodies
Art. 34 Subsidiaries of and Subcontracting by Notified Bodies
Art. 34a Operational Obligations of Notified Bodies
Art. 35 Identification Numbers and Lists of Notified Bodies Designated Under This Regulation
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
Art. 40 Harmonised Standards
Art. 41 Common Specifications
Art. 42 Presumption of Conformity with Certain Requirements
Art. 43 Conformity Assessment
Art. 44 Certificates
Art. 45 Appeal Against Decisions of Notified Bodies
Art. 46 Information Obligations of Notified Bodies
Art. 47 Derogation From Conformity Assessment Procedure
Art. 48 EU Declaration of Conformity
Art. 49 CE Marking of Conformity
Art. 50 [Deleted]
Art. 51 Registration of Relevant Operators and of High-Risk AI Systems Listed in Annex III
Art. 52 Transparency Obligations for Providers and Users of Certain AI Systems
Art. 53 AI Regulatory Sandboxes
Art. 54 Further Processing of Personal Data for Developing Certain AI Systems in the Public Interest in the AI Regulatory Sandbox
Art. 54a Testing of High-Risk AI Systems in Real World Conditions Outside AI Regulatory Sandboxes
Art. 54b Informed Consent to Participate in Testing in Real World Conditions Outside AI Regulatory Sandboxes
Art. 55 Support Measures for Operators, in Particular SMEs, including Start-Ups
Art. 55a Derogations for Specific Operators
Art. 56 Establishment of the European Artificial Intelligence Board
Art. 57 [Deleted]
Art. 58 Tasks of the Board
Art. 58a Guidelines from the Commission on the Implementation of This Regulation
Art. 59 Designation of National Competent Authorities
Art. 60 EU Database for High-Risk AI Systems Listed in Annex III
Art. 61 Post-Market Monitoring by Providers and Post-Market Monitoring Plan for High-Risk AI Systems
Art. 62 Reporting of Serious Incidents
Art. 63 Market Surveillance and Control of AI Systems in the Union Market
Art. 63a Supervision of Testing in Real World Conditions by Market Surveillance Authorities
Art. 64 Powers of Authorities Protecting Fundamental Rights
Art. 65 Procedure for Dealing with AI Systems Presenting a Risk at National Level
Art. 66 Union Safeguard Procedure
Art. 67 Compliant High-Risk or General Purpose AI Systems Which Present a Risk
Art. 68 Formal Non-Compliance
Art. 68a Union Testing Facilities in the Area of Artificial Intelligence
Art. 68b Central Pool of Independent Experts
Art. 69 Codes of Conduct for Voluntary Application of Specific Requirements
Art. 70 Confidentiality
Art. 71 Penalties
Art. 72 Administrative Fines on Union Institutions, Agencies and Bodies
Art. 73 Exercise of the Delegation
Art. 74 Committee Procedure
Art. 75 Amendment to Regulation (EC) No 300/2008
Art. 76 Amendment to Regulation (EU) No 167/2013
Art. 77 Amendment to Regulation (EU) No 168/2013
Art. 78 Amendment to Directive 2014/90/EU
Art. 79 Amendment to Directive (EU) 2016/797
Art. 80 Amendment to Regulation (EU) 2018/858
Art. 81 Amendment to Regulation (EU) 2018/1139
Art. 82 Amendment to Regulation (EU) 2019/2144
Art. 83 AI Systems Already Placed on the Market or Put Into Service
Art. 84 Evaluation and Review
Art. 85 Entry Into Force and Application
(1) Uniform Framework for Artificial Intelligence
(2) Uniform Obligations for Operators for a High Level of Protection
(3) Economic and Social Benefits of Artificial Intelligence
(4) Protecting Public Interests and Rights under Union Law
(5) Harmonised Rules on Artificial Intelligence
(5a) Harmonised Rules on Placing AI Systems on the Market
(6) AI System
(6a) Machine Learning Approaches
(6b) Machine Learning Approaches Logic and Knowledge-Based Approaches
(6c) Machine Learning Approaches Ensuring Uniform Conditions for Regulation Implementation
(6d) The Notion of User
(7) Biometric Data
(8) Biometric Identification System
(9) Publicly Accessible Space
(10) Protection of Rights and Freedoms Across the Union
(11) Scope of the Regulation
(12) Application of Regulation to Union Bodies Providing or Using AI Systems
(-12a) Military, Defence, or National Security Purposes
(12a) Liability of Intermediary Service Providers
(12b) Respect for Scientific Research and Development
(12c) General Purpose AI Systems
(13) Establishment of Standards for High-Risk AI Systems
(14) Proportionate and Effective Risk-Based Approach
(15) Prohibited Practices of Artificial Intelligence
(16) Distortion of Human Behaviour
(17) Prohibited Social Scoring of Natural Persons
(18) Real-Time Biometric Identification by Law Enforcement
(19) Exceptions to the Use of Biometric Identification Systems
(20) Establishment of Limits to Real-Time Biometric Identification Systems
(21) Authorisation of Real-Time Remote Biometric Identification Systems in Publicly Accessible Space
(22) Member State Authorisation of Biometric Identification Systems
(23) Processing of Biometric Data
(24) Compliance with Appropriate Requirements for Biometric Identification
(25) Rules Not Applicable to Ireland
(26) Rules Not Applicable to Denmark
(27) Mandatory Requirements for Union Market Deployment
(28) Mitigation of Safety Risks to Ensure Fundamental Rights
(29) Amendment of EU Acts to Meet Mandatory Requirements for High-Risk AI Systems
(30) Classification of Products as High-Risk
(31) Classification of AI System as High-Risk
(32) Classification of Safety Components by Intended Purpose
(33) Appropriate Measures for Real-time and Remote Biometric Identification
(34) Classification of High-Risk Systems for Management and Operation
(35) Classification of High-Risk Systems for Education and Vocational Training
(36) Classification of High-Risk Systems for Employment and Selection
(37) Creditworthiness of Natural Persons
(38) Classification of High-Risk Systems for Law Enforcement Authorities
(39) Classification of High-Risk Systems for Migration and Asylum for Public Authority Use
(40) Classification of High-Risk Systems for Justice
(41) Lawfulness of AI System Use
(42) Mandatory Requirements for Risk Mitigation
(43) Requirements for High-Risk AI Systems
(44) Implementing Data Governance and Management Practices
(44a) Application of Data Minimisation Throughout AI System Lifecycle
(45) Participation in Data Sharing
(46) Record Keeping Requirements
(47) The Principle of Transparency
(48) Human Oversight Measures
(49) Appropriate Level of Accuracy, Robustness and Cybersecurity
(50) The Principle of Robustness
(51) Protecting Cybersecurity
(52) Consistency of Applicable Rules for Union Harmonisation
(52a) Setting Obligations for Operators within the AI Value Chain
(53) Responsibility of the Provider
(54) Establishment of Quality Management System
(54a) Obligations for Natural or Legal Persons as a Provider
(55) Manufacturer Obligations Under New Legislative Framework
(56) Appointment of Authorised Representative
(56a) Role of Authorised Representative for Providers Outside of the Union
(57) [Deleted]
(58) Responsibilities for Users
(58a) Protection of Data Subjects Rights
(59) [Deleted]
(60) [Deleted]
(61) Harmonised Standards
(61a) Conformity under a Cybersecurity Scheme
(62) Conformity Assessment for Trustworthiness
(63) Minimisation of Operational Duplication
(64) Scope of Application of Third-Party Conformity Assessment for High-Risk AI Systems
(65) Designating Notified Bodies for Third-Party Conformity Assessment
(66) Conformity Assessment on Substantial Modification
(67) CE Marking
(68) Exemptions to Conformity Assessment
(69) Register Requirements for High-Risk AI Systems
(70) Transparency and Notification Obligations for AI Interactions with Natural Persons
(71) Establishment of Artificial Intelligence Regulatory Sandboxes
(72) Rules for Uniform Regulatory Sandbox Implementation
(-72a) Legal Basis for Participant Use of Personal Data in Regulatory Sandbox
(72a) Guarantees for Providers or Prospective Providers
(73) Accounting for the Interests of Small-Scale Providers
(73a) EU Funded Programmes and Project Contributions
(74) Expert Contributions to Regulation Implementation
(74a) Exemptions for Microenterprises
(75) Providing Access to Testing and Experimentation Facilities for Conformity Assessment
(76) Establishment of a European Artificial Intelligence Board
(76a) Enforcement and Capacities for Member States
(77) Member State Supervisory Authorities
(78) Establishment of Post-Market Monitoring System
(79) Application of Regulation (EU) 2019/1020 and Access to Documentation
(79a) Establishment of Safeguard Procedure for AI Systems
Annex I: [Deleted]
Annex II: List of Union Harmonisation Legislation
Annex III: High-Risk AI Systems Referred (6)3
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 VIIIa: 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 54a
Annex IX: Union Legislation on Large-Scale IT Systems in the Area of Freedom, Security and Justice
Key Issue 1: Fines/Penalties
Key Issue 2: Conformity Assessment and Self-Assessment
Key Issue 3: Risk-Based Approach
Key Issue 4: Human Oversight
Key Issue 5: Transparency Obligations
Key Issue 6: Interplay with GDPR
AI Act
Recitals
Annexes
Key Issues
News
Latest version of the text, as of
25 November 2022
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Privacy Policy | Liability
Recital 60
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