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MDCG 21-28 – Substantial modification of clinical investigation under Medical Device Regulation

The document, endorsed by the Medical Device Coordination Group, is intended to be facilitative and its use by the Competent Authorities and sponsors is encouraged, however it is important to check with the individual Member State in which the clinical investigation is taking place or planned to be conducted as to any specific national requirements.

Read the news announcement published by the European Commission on 9 December 2021.


OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (14 mars 2022). MDCG 21-28 – Substantial modification of clinical investigation under Medical Device Regulation. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/o5vh


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