The mutual recognition agreement (MRA) between EU and Switzerland was not closed successfully and therefore there will be a new route to market in Switzerland. Manufacturers outside
of Switzerland will have to appoint a Swiss Authorized Representative to register their devices
with the Swiss competent authority, Swiss medic.
Qserve will offer this service through a partner that is located in Switzerland and registered with
Swiss medic as a Swiss Authorized Representative to register the manufacturers’ medical devices.
One of the responsibilities of a Swiss Rep is accessing the technical documentation and ensuring it
is in compliance with the applicable regulations