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Article 37

Challenge to the competence of notified bodies

1.   The Commission shall, where necessary, investigate all cases where there are reasons to doubt the competence of a notified body or the continued fulfilment by a notified body of the requirements laid down in Article 31 and of its applicable responsibilities.

2.   The notifying authority shall provide the Commission, on request, with all relevant information relating to the notification or the maintenance of the competence of the notified body concerned.

3.   The Commission shall ensure that all sensitive information obtained in the course of its investigations pursuant to this Article is treated confidentially in accordance with Article 78.

4.   Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension or withdrawal of the notification if necessary. Where the Member State fails to take the necessary corrective measures, the Commission may, by means of an implementing act, suspend, restrict or withdraw the designation. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).

Frequently Asked Questions

If the European Commission finds out that a notified body is not meeting the necessary standards, it tells the relevant Member State, instructing them to fix the problem, possibly by suspending or withdrawing that body’s approval; if the Member State doesn’t act, the Commission itself can step in and suspend or withdraw the body’s designation directly.
The authority that originally notified or approved the notified body is responsible for providing detailed information to the European Commission whenever requested, such as when there are doubts about whether the notified body still meets the required standards or obligations outlined in the law.
All sensitive information obtained by the European Commission during its investigations into a notified body’s competence must be kept confidential, meaning that it cannot be shared publicly or with unauthorized persons, and must be handled according to strict privacy regulations outlined elsewhere in the AI Act.
Yes, if a Member State does not take appropriate action after the Commission points out issues about a notified body’s competence, the Commission itself has the power, through an official implementing act, to directly suspend, limit, or withdraw the body’s approval under specific procedures mentioned in the AI Act.

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