Article 46 Challenge of the competence of notified bodies

The Commission shall investigate all cases where it doubts, or where doubt is brought to its attention regarding, the competence of a notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; to meet, or the continued fulfilment by a notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; of, the requirements and responsibilities to which it is subject.

The notifying Member State shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the body concerned.

The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.

Where the Commission ascertains that a notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; 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 de-notification if necessary.