Europe: The European Medical Device Regulations are Now in Full Force

ARQon
Sep 20, 2021
1 min read

Official European Commission journal has published the Medical Device Regulation 2017/745 (MDR) in 2017 and was planned to be enforced in 26 May 2020. However, due to pandemic covid-19 situation, the enforcement has been delayed until 26 May 2021. Hence, the MDR's application date is now later than Brexit's deadline of December 31, 2020. As a result, the MDR does not take effect automatically in England, Scotland, or Wales.

Since the transition period has ended on 26 May 2021, there will be no further certification under Directives 90/385/EEC and 93/42/EEC. However, devices in the market that are under these two certification remain valid until their certificate expiry date or until 26 May 2024, whichever comes first, with a sell-off period that lasts until 26 May 2025. Nevertheless, this device must still meet the MDR's post-market surveillance, market surveillance, vigilance, economic operator registration, and device registration requirements.

Medical Device Coordination Group (MDCG) has published list of guidance to help industry to comply MDR regulations. Since the change from MDD to MDR is so significant, several aspects of the MDR are still being unravelled in the near future.

Sources:

MDR-certified notified bodies

Guidance - MDCG endorsed documents and other guidance

MDR and IVDR implementing measures rolling plan

Regulation (EU) 2017/745 (EU MDR)