Swiss Exit: what requirements should EU Manufacturers of Medical Devices satisfy now?

As of May 26, 2021, Switzerland has fully-fledged become a Third Country (Swiss Exit) and Swiss Manufacturers are treated as any other extra-EU Manufacturer. Therefore, non-Swiss Manufacturers will have to appoint Swiss Authorised Representatives and Importers based in Switzerland. In other words, Medical Devices Manufacturers with head office outside Swiss territory have to appoint the “Swiss Representative” (also known as Swiss REP or CH REP) located in Switzerland, whose name must be written on the product and on the labelling together with potential Importers for Switzerland.

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