The proposal for a one-year delay of Regulation (EU) 2017/745 on medical devices (MDR) that was proposed the European Commission has been confirmed by the European Parliament. The last step in the process will be a sign-off by the European Council. This is rather a formality – as such, experts agree that economic operators may adapt their transition plans accordingly.
Basic information about the MDR delay
- The MDR date of application (DoA) will be delayed to May 26, 2021. Products that comply with the MDD and AIMDD may be placed on the market until May 25, 2021 accordingly.
- The grace period, which has been granted for MDD products with a valid CE certificate issues by a Notified Body or for certain class I medical devices (e.g. reusable surgical instruments, inhalers, some substance-based and software products) has not been extended.
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) will not be postponed.
- Other deadlines, e.g. the delayed introduction of EUDAMED or UDI labeling requirements, have not been mentioned in the proposal and are thus not affected.
Happy about the postponement? Act with caution!
Although the postponement brings some relief for all parties involved, manufacturers and all economic operators involved should use the additional time wisely. Many of the problems we are currently facing are not necessarily resolved by an additional delay.
In his recent blog, Erik Vollebregt appropriately posted that the additional time won’t bring and additional resources. It is thus very likely that Notified Bodies will have the same capacity issues they already have today.
Also, the European Commission may not be able to provide economic operators with the guidance that is urgently needed because the COVID-19 crisis will keep also public authorities busy. In sum, things might get even more difficult, because the MDR DoA, EUDAMED introduction and IVDR DoA will all fall into a very limited time frame.
An appeal to all economic operators
Experts have warned broadly to not wait until the last minute to complete the MDR transition. Use the additional time and make the most of it. Early birds will have less problems related to limited capacities.
So please don’t wait until 2021 to set up the required documentation and continue with your transition process immediately. This will help you to safeguard a smooth transition process!
Source: Medtech Insight (an Informa product), medicaldeviceslegal blog