CHAPTER III

Article 37: Challenge to the competence of notified bodies

Plain English Summary

What this article does: Allows the Commission to investigate and challenge the competence of notified bodies. Who it applies to: The Commission, notifying authorities, and notified bodies. Key requirements: Para 1: The Commission may investigate where there are doubts about a notified body's competence or ongoing compliance. Para 2: The Commission must provide the notifying authority with all relevant information. Para 3: The notifying authority must take all appropriate measures, which may include restricting, suspending, or withdrawing the notification.

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 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 (2).

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