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Chapter IIIHigh-Risk

Article 36

Challenge to the Competence of Notified Bodies

Plain-Language Summary

Where concerns arise about a notified body's competence, the Commission, in consultation with Member States, may investigate. If the body is found non-compliant, the Member State must take corrective action.

Keywords

notified bodiescompetencechallengeCommissioninvestigationaccountability

Legal Text

Article 36 — Challenge to the Competence of Notified Bodies

1. The Commission shall investigate all cases where it has doubts, or doubt is brought to its attention, as to whether a notified body meets the requirements set out in Article 29.

2. 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 notified body concerned.

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