Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP)
This scientific opinion reflects the views of independent experts (MDR Article 106) on the clinical evaluation assessment report (CEAR) of the notified body. The advice is provided in the context of the clinical evaluation consultation procedure (CECP), which is an additional element of conformity assessment by notified bodies for specific high-risk devices (MDR Article 54 and Annex IX, Section 5.1).
Read the news announcement published by Directorate-General for Health and Food Safety on 12 March 2025.
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lsgilbert (23 avril 2025). Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP). ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/13sl7





