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Table of Contents
Chapter I: General Provisions
Art. 1 Subject MatterArt. 2 ScopeArt. 3 DefinitionsArt. 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 IIISection 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 SubcontractingArt. 34 Operational Obligations of Notifed 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 Users 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 ProcedureSection 2: Obligations for Providers of General Purpose AI Models
Art. 53 Obligations for Providers of General-Purpose AI ModelsArt. 54 Further Processing of Personal Data for Developing Certain AI Systems in the Public Interest in the AI Regulatory SandboxSection 3: Obligations for Providers of General Purpose AI Models with Systemic Risk
Art. 55 Obligations for Providers of General-Purpose AI Models with Systemic RiskSection 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 SandboxesArt. 59 Further Processing of Personal Data for Developing Certain AI Systems in the Public Interest in the AI Regulatory SandboxArt. 60 Testing of High-Risk AI Systems in Real World Conditions outside AI Regulatory SandboxesArt. 61 Informed Consent to Participate in Testing in Real World Conditions Outside AI Regulatory SandboxesArt. 62 Measures for Providers and Deployers, in Particular SMEs, including Start-UpsArt. 63 Derogations for Specific Operators
Chapter VII: Governance
Section 1: Governance at Union Level
Art. 64 AI OfficeArt. 65 Establishment and Structure of the European Artificial Intelligence BoardArt. 66 Tasks of the BoardArt. 67 Advisory ForumArt. 68 Scientific Panel of Independent ExpertsArt. 69 Access to the Pool of Experts by the Member StatesSection 2: National Competent Authorities
Art. 70 Designation of National Competent Authorities and Single Points of Contact
Chapter VIII: EU Database for High-Risk 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 SystemsSection 2: Sharing of Information on Serious Incidents
Art. 73 Reporting of Serious IncidentsSection 3: Enforcement
Art. 74 Market Surveillance and Control of AI Systems in the Union MarketArt. 75 Mutual Assistance, Market Surveillance and Control of General-Purpose AI SystemsArt. 76 Supervision of Testing in Real World Conditions by Market Surveillance AuthoritiesArt. 77 Powers of Authorities Protecting Fundamental RightsArt. 78 ConfidentialityArt. 79 Procedure at National Level for Dealing with AI Systems Presenting a RiskArt. 80 Procedure for Dealing with AI Systems Classified by the Provider as Non-High-Risk in Application of Annex IIIArt. 81 Union Safeguard ProcedureArt. 82 Compliant AI Systems which Present a RiskArt. 83 Formal Non-ComplianceArt. 84 Union AI Testing Support StructuresSection 4: Remedies
Art. 85 Right to Lodge a Complaint with a Market Surveillance AuthorityArt. 86 Right to Explanation of Individual Decision-MakingArt. 87 Reporting of Infringements and Protection of Reporting PersonsSection 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 ModelsArt. 89 Monitoring ActionsArt. 90 Alerts of Systemic Risks by the Scientific PanelArt. 91 Power to Request Documentation and InformationArt. 92 Power to Conduct EvaluationsArt. 93 Power to Request MeasuresArt. 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 RequirementsArt. 96 Guidelines from the Commission on the Implementation of this Regulation
Chapter XI: Delegation of Power and Committee Procedure
Art. 97 Exercise of the DelegationArt. 98 Committee Procedure
Chapter XII: Penalties
Art. 99 PenaltiesArt. 100 Administrative Fines on Union Institutions, Bodies, Offices and AgenciesArt. 101 Fines for Providers of General-Purpose AI Models
Chapter XIII: Final Provisions
Art. 102 Amendment to Regulation (EC) No 300/2008Art. 103 Amendment to Regulation (EU) No 167/2013Art. 104 Amendment to Regulation (EU) No 168/2013Art. 105 Amendment to Directive 2014/90/EUArt. 106 Amendment to Directive (EU) 2016/797Art. 107 Amendment to Regulation (EU) 2018/858Art. 108 Amendment to Regulation (EU) 2018/1139Art. 109 Amendment to Regulation (EU) 2019/2144Art. 110 Amendment to Directive (EU) 2020/1828Art. 111 AI Systems Already Placed on the Market or Put into Service and General-Purpose AI Models Already Placed on the MarkedArt. 112 Evaluation and ReviewArt. 113 Entry into Force and Application
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Article 61

Informed Consent to Participate in Testing in Real World Conditions Outside AI Regulatory Sandboxes

1.   For the purpose of testing in real world conditions under Article 60, freely-given informed consent shall be obtained from the subjects of testing prior to their participation in such testing and after their having been duly informed with concise, clear, relevant, and understandable information regarding:

(a)

the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to their participation;

(b)

the conditions under which the testing in real world conditions is to be conducted, including the expected duration of the subject or subjects’ participation;

(c)

their rights, and the guarantees regarding their participation, in particular their right to refuse to participate in, and the right to withdraw from, testing in real world conditions at any time without any resulting detriment and without having to provide any justification;

(d)

the arrangements for requesting the reversal or the disregarding of the predictions, recommendations or decisions of the AI system;

(e)

the Union-wide unique single identification number of the testing in real world conditions in accordance with Article 60(4) point (c), and the contact details of the provider or its legal representative from whom further information can be obtained.

2.   The informed consent shall be dated and documented and a copy shall be given to the subjects of testing or their legal representative.

Suitable Recitals
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