Update – Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5
This document records the agreements reached by the Member State members of the Borderline and Classification Working Group (BCWG)1 following the exchanges under the Helsinki Procedure under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. It serves as one of the support tools for case-by-case application of the Union legislation by the Member States in their respective jurisdictions. It remains for the national competent authorities and the national courts to reach decisions at national level.
Read the news announcement published by DG Health and Food Safety on 22 April 2026.
OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (13 mai 2026). Update – Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5. ELSIBI. Consulté le 7 octobre 2026 à l’adresse https://doi.org/10.58079/167no
