Article 80: Procedure for Dealing with AI Systems Classified by the Provider as Non-High-Risk in Application of Annex III
Article 80
Procedure for Dealing with AI Systems Classified by the Provider as Non-High-Risk in Application of Annex III
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. Where a market surveillance authority has sufficient reason to consider that an AI system classified by the provider as non-high-risk pursuant to Article 6(3) is indeed high-risk, the market surveillance authority shall carry out an evaluation of the AI system concerned in respect of its classification as a high-risk AI system based on the conditions set out in Article 6(3) and the Commission guidelines.
2. Where, in the course of that evaluation, the market surveillance authority finds that the AI system concerned is high-risk, it shall without undue delay require the relevant provider to take all necessary actions to bring the AI system into compliance with the requirements and obligations laid down in this Regulation, as well as take appropriate corrective action within a period the market surveillance authority may prescribe.
3. Where the market surveillance authority considers that the use of the AI system concerned is not restricted to its national territory, it shall inform the Commission and the other Member States without undue delay of the results of the evaluation and of the actions which it has required the provider to take.
4. The provider shall ensure that all necessary action is taken to bring the AI system into compliance with the requirements and obligations laid down in this Regulation. Where the provider of an AI system concerned does not bring the AI system into compliance with those requirements and obligations within the period referred to in paragraph 2 of this Article, the provider shall be subject to fines in accordance with Article 99.
5. The provider shall ensure that all appropriate corrective action is taken in respect of all the AI systems concerned that it has made available on the Union market.
6. Where the provider of the AI system concerned does not take adequate corrective action within the period referred to in paragraph 2 of this Article, Article 79(5) to (9) shall apply.
7. Where, in the course of the evaluation pursuant to paragraph 1 of this Article, the market surveillance authority establishes that the AI system was misclassified by the provider as non-high-risk in order to circumvent the application of requirements in Chapter III, Section 2, the provider shall be subject to fines in accordance with Article 99.
8. In exercising their power to monitor the application of this Article, and in accordance with Article 11 of Regulation (EU) 2019/1020, market surveillance authorities may perform appropriate checks, taking into account in particular information stored in the EU database referred to in Article 71 of this Regulation.
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