The European Commission has published a notice to stakeholders on 24th May regarding the «Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices».
There are no positive surprises. In the absence of an update of the MRA to include the IVDR, the part of the MRA chapter covering in vitro diagnostic medical devices ceases to apply as of 26 May 2022. This means that Swiss manufacturers of in vitro diagnostic medical devices will be treated as third country manufacturer and must designate an authorised representative established in the EU and label the products accordingly.