Art. 68e [Deleted]

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Table of Contents

Chapter I: General Provisions

Art. 1 Subject Matter Art. 2 Scope Art. 3 Definitions Art. 4 AI Literacy

Chapter II: Prohibited Artificial Intelligence 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
Chapter 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. 23a [Deleted]
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. 29a [Deleted]
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. 33a [Deleted]Art. 34 Operational Obligations of Notifed Bodies
Art. 34a [Deleted]
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: Measures in Support of Innovation

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. 53a [Deleted]Art. 54 Further Processing of Personal Data for Developing Certain AI Systems in the Public Interest in the AI Regulatory Sandbox Art. 54a [Deleted]Art. 54b [Deleted]Section 3: Obligations for Providers of General Purpose AI Models with Systemic Risk
Art. 55 Obligations for Providers of General-Purpose AI Models with Systemic Risk Art. 55a [Deleted]Art. 55b [Deleted]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. 58a [Deleted]Art. 58b [Deleted]Art. 58c [Deleted]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 Art. 63a [Deleted]Art. 63b [Deleted]

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 , Market Surveillance

Section 1: Post-Market Monitoring
Art. 72 Post-Market Monitoring by Providers and Post-Market Monitoring Plan for High-Risk AI Systems Art. 72a [Deleted]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. 82a [Deleted]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 Amendment 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 Art. 112 Evaluation and Review Art. 113 Entry into Force and Application

Article 68e

[Deleted]

‍Removed on April 10^th 2024 based on the version and article numbering approved by the EU Parliament on March 13^th 2024.

‍

[Previous version]

Updated on Feb 6^th 2024 based on the version endorsed by the Coreper I on Feb 2^nd

Reporting of Breaches and Protection of Reporting Persons

Directive (EU) 2019/1937 of the European Parliament and of the Council shall apply to the reporting of breaches of this Regulation and the protection of persons reporting such breaches.

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