Summary of Article 80
- Market Surveillance Authority’s Role in Reclassifying AI Systems: Market surveillance authorities evaluate AI systems classified as non-high-risk to determine if they meet high-risk criteria, require corrective actions, and coordinate with the Commission and Member States for cross-border issues.
- Provider Responsibilities for Compliance and Corrective Actions: Providers must ensure compliance of their AI systems with regulatory requirements, take necessary corrective actions, and address all non-compliant systems in the Union market within prescribed timelines.
- Penalties for Misclassification: Providers found to have misclassified AI systems as non-high-risk to avoid regulatory requirements are subject to fines under Article 99.
Market Surveillance Authority’s Role in Reclassifying AI Systems
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.
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.
Provider Responsibilities for Compliance and Corrective Actions
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.
Penalties for Misclassification
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.
