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MDCG 2024-10 – Clinical evaluation of orphan medical devices – June 2024

This document provides guidance to manufacturers and notified bodies on the clinical evaluation pursuant to the Medical Devices Regulation (MDR) of medical devices and accessories for medical devices that qualify as ‘orphan devices’ and medical devices and accessories for medical devices that have an orphan indication, within the meaning of this guidance. This guidance is relevant to devices across all risk classes as per the classification rules defined in the MDR.

Read the news announcement published by EC Directorate-General for Health and Food Safety on 25 June 2024.


OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (8 juillet 2024). MDCG 2024-10 – Clinical evaluation of orphan medical devices – June 2024. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/11yxi


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