MRA between Switzerland and the EU

Switzerland is preparing a worst-case scenario.

MRA Swizerland and the European Union
photo: iStock MRI effect on market entry in Switzerland

April 2021 – MRA between Switzerland and the EU requires a worst-case scenario. The new EU MRI also has implications for market entry in Switzerland.

The Federal Office of Public Health (FOPH) of Switzerland has prepared an amendment to the Medical Devices Ordinance (Eventual-MepV) on behalf of the Swiss Federal Council as a precautionary measure. According to the Swiss medical technology association Swiss Medtech, this is to be put into force by the Federal Council on 26 May 2021 if the Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) has not been updated by that date.

What happens on 26 May 2021?


Swiss Medtech emphasises that an update of the MRA before 26 May 2021 is not excluded. In that case, the “ Eventual-MepV “ would not enter into force.

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