In one of our previous posts we draw your attention to the upcoming deadline of May 26th, 2020 which was the date on which the MDR, i.e. the new EU regulation concerning medical devices was expected to be fully applicable.
Due to the still ongoing discussion between Switzerland and the EU with respect to the Mutual Recognition Agreement (MRA), which until now granted a special position to Switzerland also with respect to the access of the EU medical devices market, it was expected that May 26th, 2020 may also be the date as of which the Swiss manufacturers of those medical devices would for first time need to meet the requirements of third country manufacturers when entering the EU market.
Even though there has been no news about the development in the EU-Swiss negotiations, which could secure specific status of the Swiss manufacturers, due to the COVID 19 outbreak the Commission announced on 25 March 2020 that it works on a proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year. The Commission aims to submit this proposal in early April so the Parliament and Council can adopt it by the end of May. While this proposal of Commission aims mainly to take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis, this is also very important news for the Swiss manufacturers of the medical devices as in case that MDR does not become applicable, the current rules will remain in place.
As a result it is expected that those new developments will provide the Swiss manufacturers with an additional year of status quo situation and the Swiss -EU negotiators one more year to hopefully come to agreement with respect to MRA.
Recommended next steps
- Despite the good news, the Swiss manufacturers should follow up on the EU development concerning the MDR applicability in order to be prepared for the possible upcoming changes.
- Going forward it will be also upmost important to follow up on the Swiss-EU negotiation in order to timely prepare for the worst case scenario, in which the Swiss manufacturers would need to meet the third country requirements as of May 2021.
We will of course keep you informed about the new developments and would be happy to discuss with you the steps to be relevant for your supply chain.