CHAPTER IX

Article 80: Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III

Plain English Summary

What this article does: Establishes the procedure when a provider claims its system is not high-risk but an authority disagrees. Who it applies to: Market surveillance authorities and providers of AI systems. Key requirements: Para 1: Where a market surveillance authority considers that a system classified by the provider as non-high-risk is in fact high-risk, it must require the provider to take corrective action. Para 2: The provider must comply with high-risk requirements within the timeframe set by the authority. Para 3: If the provider does not comply, the authority may restrict or withdraw the system from the market. Para 4: Must inform the Commission and other Member States.

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 (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 (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, (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 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 of this Regulation.

Cross-referenced Articles

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