Article 76: Supervision of Testing in Real World Conditions by Market Surveillance Authorities
Article 76
Supervision of Testing in Real World Conditions by Market Surveillance Authorities
Updated on 31 July 2024 based on the version published in the Official Journal of the EU dated 12 July 2024 and entered into force on 1 August 2024.
1. Market surveillance authorities shall have competences and powers to ensure that testing in real world conditions is in accordance with this Regulation.
2. Where testing in real world conditions is conducted for AI systems that are supervised within an AI regulatory sandbox under Article 58, the market surveillance authorities shall verify the compliance with Article 60 as part of their supervisory role for the AI regulatory sandbox. Those authorities may, as appropriate, allow the testing in real world conditions to be conducted by the provider or prospective provider, in derogation from the conditions set out in Article 60(4), points (f) and (g).
3. Where a market surveillance authority has been informed by the prospective provider, the provider or any third party of a serious incident or has other grounds for considering that the conditions set out in Articles 60 and 61 are not met, it may take either of the following decisions on its territory, as appropriate:
- to suspend or terminate the testing in real world conditions;
- to require the provider or prospective provider and the deployer or prospective deployer to modify any aspect of the testing in real world conditions.
4. Where a market surveillance authority has taken a decision referred to in paragraph 3 of this Article, or has issued an objection within the meaning of Article 60(4), point (b), the decision or the objection shall indicate the grounds therefor and how the provider or prospective provider can challenge the decision or objection.
5. Where applicable, where a market surveillance authority has taken a decision referred to in paragraph 3, it shall communicate the grounds therefor to the market surveillance authorities of other Member States in which the AI system has been tested in accordance with the testing plan.
Table of Contents
Chapter III: High-Risk AI Systems
- Section 1: Classification of AI Systems as High-Risk
- Section 2: Requirements for High-Risk AI Systems
- Article 8: Compliance with the Requirements
- Article 9: Risk Management System
- Article 10: Data and Data Governance
- Article 11: Technical Documentation
- Article 12: Record-Keeping
- Article 13: Transparency and Provision of Information to Deployers
- Article 14: Human Oversight
- Article 15: Accuracy, Robustness and Cybersecurity
- Section 3: Obligations of Providers and Deployers of High-Risk AI Systems and Other Parties
- Article 16: Obligations of Providers of High-Risk AI Systems
- Article 17: Quality Management System
- Article 18: Documentation Keeping
- Article 19: Automatically Generated Logs
- Article 20: Corrective Actions and Duty of Information
- Article 21: Cooperation with Competent Authorities
- Article 22: Authorised Representatives of Providers of High-Risk AI Systems
- Article 23: Obligations of Importers
- Article 23a
- Article 24: Obligations of Distributors
- Article 25: Responsibilities along the AI Value Chain
- Article 26: Obligations of Deployers of High-Risk AI Systems
- Article 27: Fundamental Rights Impact Assessment for High-Risk AI Systems
- Section 4: Notifying Authorities and Notified Bodies
- Article 28: Notifying Authorities
- Article 29: Application of a Conformity Assessment Body for Notification
- Article 30: Notification Procedure
- Article 31: Requirements Relating to Notified Bodies
- Article 32: Presumption of Conformity with Requirements Relating to Notified Bodies
- Article 33: Subsidiaries of Notified Bodies and Subcontracting
- Article 34: Operational Obligations of Notified Bodies
- Article 35: Identification Numbers and Lists of Notified Bodies
- Article 36: Changes to Notifications
- Article 37: Challenge to the Competence of Notified Bodies
- Article 38: Coordination of Notified Bodies
- Article 39: Conformity Assessment Bodies of Third Countries
- Section 5: Standards, Conformity Assessment, Certification, Registration
- Article 40: Harmonised Standards and Standardisation Deliverables
- Article 41: Common Specifications
- Article 42: Presumption of Conformity with Certain Requirements
- Article 43: Conformity Assessment
- Article 44: Certificates
- Article 45: Information Obligations of Notified Bodies
- Article 46: Derogation from Conformity Assessment Procedure
- Article 47: EU Declaration of Conformity
- Article 48: CE Marking
- Article 49: Registration
Chapter V: General-Purpose AI Models
Chapter VI: Measures in Support of Innovation
- Article 57: AI Regulatory Sandboxes
- Article 58: Detailed Arrangements for, and Functioning of, AI Regulatory Sandboxes
- Article 59: Further Processing of Personal Data for Developing Certain AI Systems in the Public Interest in the AI Regulatory Sandbox
- Article 60: Testing of High-Risk AI Systems in Real World Conditions Outside AI Regulatory Sandboxes
- Article 61: Informed Consent to Participate in Testing in Real World Conditions Outside AI Regulatory Sandboxes
- Article 62: Measures for Providers and Deployers, in Particular SMEs, including Start-Ups
- Article 63: Derogations for Specific Operators
Chapter VII: Governance
Chapter IX: Post-Market Monitoring, Information Sharing and Market Surveillance
- Section 1: Post-Market Monitoring
- Section 2: Sharing of Information on Serious Incidents
- Section 3: Enforcement
- Article 74: Market Surveillance and Control of AI Systems in the Union Market
- Article 75: Mutual Assistance, Market Surveillance and Control of General-Purpose AI Systems
- Article 76: Supervision of Testing in Real World Conditions by Market Surveillance Authorities
- Article 77: Powers of Authorities Protecting Fundamental Rights
- Article 78: Confidentiality
- Article 80: Procedure for Dealing with AI Systems Classified by the Provider as Non-High-Risk in Application of Annex III
- Article 81: Union Safeguard Procedure
- Article 82: Compliant AI Systems which Present a Risk
- Article 82a
- Article 83: Formal Non-Compliance
- Article 84: Union AI Testing Support Structures
- Article 79: Procedure at National Level for Dealing with AI Systems Presenting a Risk
- Section 4: Remedies
- Section 5: Supervision, Investigation, Enforcement and Monitoring in Respect of Providers of General-Purpose AI Models
- Article 88: Enforcement of the Obligations of Providers of General-Purpose AI Models
- Article 89: Monitoring Actions
- Article 90: Alerts of Systemic Risks by the Scientific Panel
- Article 91: Power to Request Documentation and Information
- Article 92: Power to Conduct Evaluations
- Article 93: Power to Request Measures
- Article 94: Procedural Rights of Economic Operators of the General-Purpose AI Model
Chapter XIII: Final Provisions
- Article 102: Amendment to Regulation (EC) No 300/2008
- Article 103: Amendment to Regulation (EU) No 167/2013
- Article 104: Amendment to Regulation (EU) No 168/2013
- Article 105: Amendment to Directive 2014/90/EU
- Article 106: Amendment to Directive (EU) 2016/797
- Article 107: Amendment to Regulation (EU) 2018/858
- Article 108: Amendment to Regulation (EU) 2018/1139
- Article 109: Amendment to Regulation (EU) 2019/2144
- Article 110: Amendment to Directive (EU) 2020/1828
- Article 111: AI Systems Already Placed on the Market or Put into Service and General-Purpose AI Models Already Placed on the Marked
- Article 112: Evaluation and Review
- Article 113: Entry into Force and Application