MDCG 2022-3 rev.1 – Verification of manufactured class D IVDs by notified bodies (December 2024)
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establishes the requirements for notified bodies involved in the conformity assessment of applicable classes of in vitro diagnostic medical devices (IVDs). Manufacturers must demonstrate that the devices conform to relevant requirements based upon objective evidence and analysis.
Read the news announcement published by Directorate-General for Health and Food Safety on 18 December 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (12 janvier 2025). MDCG 2022-3 rev.1 – Verification of manufactured class D IVDs by notified bodies (December 2024). ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/132ed





