On April 3rd, the European Commission adopted a proposal to delay the application of the EU MDR by one year, to May 26, 2021 in order to allow “Member States, health institutions and economic operators to prioritize the fight against the coronavirus pandemic.”
What does this mean for global healthcare?
This is a positive outcome for healthcare systems across the EU, as it provides for uninterrupted access to vital life-saving devices.
Vice-President for Promoting our European Way of Life, Margaritis Schinas, said: “Shortages or delays in getting key medical devices certified and on the market are not an option right now. The Commission is therefore taking a pragmatic approach and delaying the entry into application of new EU rules on medical devices, so we can have our medical industries pouring all their energy into what we need them to be doing: helping fight the pandemic.”
Stella Kyriakides, Commissioner for Health and Food Safety, added: “Any potential market disruptions regarding the availability of safe and essential medical devices must and will be avoided.”
What does this mean for manufacturers?
The delay is also a positive outcome for device manufacturers. First, it obviously means more time to become compliant. According to industry polls, around 40% of manufacturers weren’t going to be fully compliant by the May 26 deadline. Now there’s enough time to get processes and documentation in shape, including preparing all required translations.
Second, it means more access to notified bodies. There are only 11 MDR-designated notified bodies today. The extension should allow for more notified bodies and increased overall capacity.
Third, it means that manufacturers are able to prepare multilingual documentation for all of their target markets in the EU. There’s an enormous volume of documentation under the MDR that must be translated into the official language(s) of each country. Many companies were prioritizing languages in order to meet the deadline, but now there’s sufficient time to prepare documentation for all intended EU markets.
Stay current & keep in touch
For a refresher on the complex EU MDR language requirements, take a look at our recent webinar that we co-produced with RAPS.
If you have any questions about translating your documentation or MDR compliance in general, please contact us directly.