Swiss Medtech calls for the update of the Mutual Recognition Agreement with the EU

In the referendum that was held on September 27, 2020, the Swiss population and cantons rejected ‘’the limitation initiative’’, which demonstrates the public’s approval of their bilateral path with the EU.

In view of the Medical Device Regulation (MDR) becoming fully applicable in the EU next May 26, 2021, the Swiss medical technology sector could be the first industry to take into account the referendum’s  results and reinforce relationships with the EU.


More precisely, Swiss Medtech urges for a quick and pragmatic solution for an agreement which will eliminate technical barriers to trade medical devices. Swiss Medtech reminds that if the Mutual Recognition Agreement (MRA) is not updated by May 2021, the industry will lose its direct access to the EU Single Market. Due to the urgency, Swiss Medtech is calling on the Federal Council to prioritize this matter and adopt a pragmatic solution for the MRA with the EU for medical device industry.

While hoping the MRA will be updated prior the MDR becomes fully applicable, Obelis recommends the manufacturers to act now and assure compliance before May 2021.


Nika Gavrilovic

RA Junior Consultant

15/10/2020


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References:

Swiss Medtech (27/09/20). Solid basis for next important step with Europe. Swiss Medtech calls for quick, pragmatic solution for medtech industry. Retrieved on 15/10/20 from https://www.swiss-medtech.ch/en/news/solid-basis-next-important-step-europe.