Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2022)
The manual records the agreements reached by the Member State members of the Borderline and Classification Working Group (BCWG) following the exchanges under the Helsinki Procedure under Regulation (EU) 2017/745 on medical devices (the MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR).
Read the news announcement published by EC Directorate-General for Health and Food Safety on 7 September 2022.
OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (24 octobre 2022). Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2022). ELSIBI. Consulté le 19 janvier 2025 à l’adresse https://doi.org/10.58079/o637