Yesterday (26 May 2020) would have been the official implementation date of the Medical Device Regulation, but due to the coronavirus, the date has been postponed by one year.
This delay may have come as a pleasant surprise for those pressed for time prior to the implementation date. Please bear in mind, however, that the postponement of the MDR does not mean a more relaxed transition period.
As the industry prioritises the battle against the pandemic, expect further delays in conformity assessment procedures. COVID-19 will continue to affect the following:
- Clinical trials
- Supply chains
- Notified Bodies
There are currently only 12 accredited Notified Bodies in the European Union, and the bottleneck of MDR applications will lead to long waiting periods in the upcoming year (the same goes for quality system inspections). The only way to ensure compliance is therefore to submit your technical file as soon as possible.
The industry must be MDR compliant by 26 May 2021. If your technical file is not yet compliant with the MDR, we advise you to begin immediately with identifying the gaps and making a plan to meet the new deadline.
If you have questions about MDR compliance, our CE medical team is happy to help. We can carry out a gap analysis and guide you through the steps it takes to ensure conformity before the new MDR implementation date.