Article 37 Challenge to the competence of notified bodies
1.
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.
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.
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.
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).
Drafting History 2 ▾
Case Law 0 ▾
2021-04-21
Commission Proposal — COM(2021) 206 final
Article 37 — Challenge to the competence of notified bodies
1. The Commission shall, where necessary, investigate all cases where there are reasons to doubt whether a notified body complies with the requirements laid down in Article 33. 2. The Notifying authority shall provide the Commission, on request, with all relevant information relating to the notification of the notified body concerned. 3. The Commission shall ensure that all confidential information obtained in the course of its investigations pursuant to this Article is treated confidentially. 4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements laid down in Article 33, it shall adopt a reasoned decision requesting the notifying Member State to take the necessary corrective measures, including withdrawal of notification if necessary. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 74(2).
July 2024
Final Adopted Text — Regulation (EU) 2024/1689
Article 37 — Challenge to the competence of notified bodies
4 paragraph(s) · Current text shown above
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No case law referencing Article 37 yet.
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