Category Medical Devices Coordination Group

MDCG updates August 2021

The Medical Device Coordination Group (MDCG) has published the following updates: MDCG number Notes MDCG 2021- 23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746…

MDCG issues guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional

The Medical Devices Coordination Group (MDCG) has issued guidance MDCG 2021-1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional. Article 33 of Regulation (EU) 2017/745 on medical devices1 (MDR) requires the Commission to set…