MDCG 2023-7 – Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR – December 2023
This guidance is intended to clarify the exemptions from the requirement to perform clinical investigations, and associated conditions related to the demonstration of equivalence, for implantable and class III medical devices to be placed on the European market. It also provides examples and considerations relevant to the demonstration of “sufficient levels of access to the data” per Annex XIV Section 3.
Read the news announcement published by EC Directorate-General for Health and Food Safety on 21 December 2023.
OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (13 février 2024). MDCG 2023-7 – Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR – December 2023. ELSIBI. Consulté le 11 octobre 2026 à l’adresse https://doi.org/10.58079/vts8
