MRA: Switzerland is preparing a worst-case-szenario
April 2021 – MRA between Switzerland and the EU has to be updated. The new MDR has implications for the market introduction of medical devices in Switzerland.
The Swiss Federal Office of Public Health (FOPH) has prepared an amendment to the Medical Devices Ordinance (Eventual-MepV) on behalf of the Swiss Federal Council as a precautionary measure. According to Swiss Medtech, the Swiss medical technology association, 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 21 May 2021?
In this context, 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.