List of views provided under the PECP – IVD-2024-000021-view
This scientific view reflects the opinion of independent experts (MDR Article 106.1) on the performance evaluation report (PER) of the manufacturer. The advice is provided in the context of the performance evaluation consultation procedure (PECP), which is an additional element of conformity assessment by notified bodies for specific high-risk in vitro diagnostic devices (IVDR Article 48.6).
Read the news announcement published by EC Directorate-General for Health and Food Safety on 27 November 2024.
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lsgilbert (10 décembre 2024). List of views provided under the PECP – IVD-2024-000021-view. ELSIBI. Consulté le 7 octobre 2026 à l’adresse https://doi.org/10.58079/12vxr
