COCIR requests negative opinion on the draft standardisation request for the Medical Device Regulations (MDR & IVDR)

The new Medical Device Regulation (MDR) will apply from 26 May 2021 (26 May 2022 for the IVDR) with the intent to provide “a high level of protection of health for patients and users and the smooth functioning of the internal market” (MDR, Recital 1). Articles 8 and 9 of both, MDR and IVDR, indicate that “conformity with the relevant harmonised standards” is the preferred way of demonstrating conformity with the legal requirements to achieve this intent. COCIR, the voice of the European medical imaging, radiotherapy, health ICT and electromedical industries, strongly believes in the need for a comprehensive and coherent set of harmonised standards to support and achieve this goal.

Read COCIR full statement in Related Files