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Article 63b

Supervision of Testing in Real World Conditions by Market Surveillance Authorities

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

1. Market surveillance authorities shall have the competence 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 54, the market surveillance authorities shall verify the compliance with the provisions of Article 54a 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 to the conditions set out in Article 54a(4) (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 54a and 54b are not met, it may take any of the following decisions on its territory, as appropriate:

  1. suspend or terminate the testing in real world conditions;
  2. require the provider or prospective provider and user(s) 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 54a(4)(b), the decision or the objection shall indicate the grounds thereof and the modalities and conditions for the provider or prospective provider to challenge the decision or objection.

5. Where applicable, where a market surveillance authority has taken a decision referred to in paragraph 3 of this Article, it shall communicate the grounds therefor to the market surveillance authorities of the other Member States in which the AI system has been tested in accordance with the testing plan.

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