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

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[Previous version]

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

Procedure for Dealing with AI Systems Classified by the Provider as a Not High-Risk in Application of Annex III

1. Where a market surveillance authority has sufficient reasons to consider that an AI system classified by the provider as non-high-risk in application of Annex III is high-risk, they 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 Annex III 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 it 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 the requirements and obligations of this Regulation within the period referred to in paragraph 2, the provider shall be subject to fines in accordance with Article 71.

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 market throughout the Union.

6. Where the provider of the AI system concerned does not take adequate corrective action within the period referred to in paragraph 2, then the provisions of Article 65 paragraphs 5 to 9 apply.

7. Where, in the course of that evaluation pursuant to paragraph 1, the market surveillance authority establishes that the AI system was misclassified by the provider as not high-risk to circumvent the application of requirements in Title III, Chapter 2, the provider shall be subject to fines in accordance with Article 71.

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 60.