On the IVDR’s date of application, the Swiss-EU Mutual Recognition Agreement (MRA) for IVDs lapsed.
Due to larger political reasons, the MRA does not include a provision for the In Vitro medical device Regulation (IVDR). Therefore, Switzerland becomes a ‘third country’ to Europe as it relates to IVDs.
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 IVDR into its legislation, other than the country-specific differences, such as the appointment of a Swiss AR instead of an EU AR.