The framework agreements between Switzerland and the EU have not yet been signed. As a result, a Swiss authorized representative will be required from May 26, 2021 due to the lack of MRA and the Swiss Medical Devices Ordinance (MepV).
This applies to CE-marked medical devices from manufacturers in the EU and outside the EU that are to be sold in Switzerland. The requirements of Article 11 of the European Medical Devices Regulation 2017/745 (MDR) also apply to the Swiss authorized representative.
This authorized representative is based in Switzerland and acts on behalf of the manufacturer when contacting the Swiss authority Swissmedic. Products that are exported to Switzerland after May 26, 2021 must be marked accordingly.
Do you or your trading partners need a Swiss authorized representative?
Please contact
FG Health Concepts
Baarerstrasse 101
CH 6300 train
Contact us for individual and tailor-made information!
