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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 [...]

2022-07-28T15:37:34+02:00December 14th, 2021|FAQ, Switzerland|

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 absence of any institutional agreement between Switzerland and Europe, Switzerland is officially considered a Third Country by Europe. The Mutual Recognition Agreement (MRA), which is a pre-condition to market products barrier-free, has not been [...]

2022-07-28T15:37:12+02:00December 14th, 2021|FAQ, Switzerland|

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 covered by a certificate still valid in compliance with the MDD / AIMDD Directives and class I devices that will require the intervention of a Notified Body (ON) which can continue to be made [...]

2021-12-14T11:24:55+01:00December 14th, 2021|FAQ, Switzerland|

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 need to register directly on Swissmedic and to obtain Swiss single identification number which is the Swiss Single Registration Number (CHRN). The Swiss Single Registration Number (CHRN) is a single identification number given from [...]

2021-12-14T11:19:43+01:00December 14th, 2021|FAQ, Switzerland|

Who is responsible for the CH REP Swiss Authorised Representative designation?

All Manufacturers located outside Switzerland who intend to start or keep marketing their own Medical Devices in Switzerland must designate a Swiss Authorised Representative CH REP. Discover the strategic-regulatory consultancy services Thema THEMA SWISS NEWS Do you want to stay updated on the main news regarding the Switzerland – EU Agreement in the field of [...]

2021-12-14T11:11:28+01:00December 14th, 2021|FAQ, Switzerland|
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