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 [...]
14 12 2021
14 12 2021
14 12 2021
14 12 2021
Why is Switzerland considered a Third Country by Europe?
Starting from May 26, 2021, in accordance with the full application of MDR (EU) 2017/745 Regulation on Medical Devices and in [...]
14 12 2021
14 12 2021
For which Medical Devices is it necessary to appoint a Swiss Authorised Representative?
The designation of the Swiss Authorised Representative (CH REP) is required to market all Medical Devices, including legacy devices, i.e. devices [...]
14 12 2021
14 12 2021
Do Swiss Authorised Representative and Importers of Medical Devices have to register in EUDAMED?
Since Switzerland is considered a Third Country by the EU, its registration database is denied. Swiss REP and Importer in Switzerland [...]
