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Swiss Authorized Representative | Swiss Market access

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

 

Daniëlle Motta
Max van Regteren
Post date: July 15, 2021
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