MDCG 2024-11 – Guidance on qualification of in vitro diagnostic medical devices (October 2024)
The purpose of this guidance document is to clarify what products fall in scope of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) – also referred to as ‘qualification’ as an in vitro diagnostic medical device (IVD) or an accessory to an IVD. In order to be qualified as an IVD or an accessory to an IVD, the product must fulfil the definition in Art 2(2) or Art 2(4) of the IVDR respectively. The qualification depends on the intended purpose as described by the manufacturer.
Read the news announcement published by EC Directorate-General for Health and Food Safety on 8 October 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (11 novembre 2024). MDCG 2024-11 – Guidance on qualification of in vitro diagnostic medical devices (October 2024). ELSIBI. Consulté le 16 janvier 2025 à l’adresse https://doi.org/10.58079/12nhj
