MDCG 2021-21 Rev.1 – Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices
The guidance document endorsed by the Medical Device Coordination Group (MDCG) concerns performance evaluation of SARS–CoV–2 in vitro diagnostic medical devices (IVDs) in the context of conformity assessment under either Directive 98/79/EC or Regulation (EU) 2017/746.
Read the news announcement published by the European Commission on 15 February 2022.
OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (15 mars 2022). MDCG 2021-21 Rev.1 – Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices. ELSIBI. Consulté le 18 janvier 2026 à l’adresse https://doi.org/10.58079/o5wz





