MDR – Article 55 – Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices

Article 55

Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices

1. A notified body shall notify the competent authorities of certificates it has granted to devices for which the conformity assessment has been performed pursuant to Article 54(1). Such notification shall take place through the electronic system referred to in Article 57 and shall include the summary of safety and clinical performance pursuant to Article 32, the assessment report by the notified body, the instructions for use referred to in Section 23.4 of Annex I, and, where applicable, the scientific opinion of the expert panels referred to in Section 5.1 of Annex IX or Section 6 of Annex X, as applicable. In the case of divergent views between the notified body and the expert panels, a full justification shall also be included.

2. A competent authority and, where applicable, the Commission may, based on reasonable concerns apply further procedures in accordance with Article 44, 45, 46, 47 or 94 and, where deemed necessary, take appropriate measures in accordance with Articles 95 and 97.

3. The MDCG and, where applicable, the Commission, may, based on reasonable concerns, request scientific advice from the expert panels in relation to the safety and performance of any device.

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