Summary of Article 37
- Investigation and Provision of Information: The Commission must investigate cases of doubts about a notified body’s competence or compliance and may request all relevant information from notifying authorities.
- Confidentiality and Corrective Actions: The Commission must treat sensitive information obtained during investigations confidentially and can request Member States to take corrective measures or directly suspend, restrict, or withdraw a notified body’s designation if necessary.
Investigation and Provision of Information
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.
Confidentiality and Corrective Actions
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).
