Swiss-EU MRA Lapses for Medical Devices

On the MDR’s date of application, the Swiss-EU Mutual Recognition Agreement (MRA) for medical devices lapsed. Due to larger political reasons, the MRA does not include a provision for the Medical Device Regulation (MDR). Therefore, Switzerland becomes a ‘third country’ to Europe as it relates to medical devices.

Swiss manufacturers require an EU Authorized Representative (AR) to market in the EU and all non-Swiss manufacturers require a Swiss Authorized Representative to market in Switzerland. Swissmedic provides a transition period to appoint the CH-REP. The EU does not provide a transition period.

Swissmedic has implemented the MDR into its legislation, other than the country-specific, such as the appointment of a Swiss AR instead of an EU AR.

Click here for the EU Commission’s official notice.