Article 37: Challenge to the Competence of Notified Bodies

Comes into force 2 August 2025, according to Article 113(b)

1. The Commission shall, where necessary, investigate all cases where there are reasons to doubt the competence of a notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) or the continued fulfilment by a notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) of the requirements laid down in Article 31 and of its applicable responsibilities.

2. The notifying authoritynotifying authoritymeans the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoringArticle 3(19) shall provide the Commission, on request, with all relevant information relating to the notification or the maintenance of the competence of the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) 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 bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) 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).