Swiss Authorised Representative: All you need to Know
Since 26 May 2021, with the full application of the Medical Device Regulation MDR (EU) 2017/745 and in the absence of an institutional agreement reached, Switzerland is officially considered a “Third Country” for Europe.
This means that Swiss Manufacturers must appoint a European Authorised Representative to export their devices to Europe. At the same time, European Manufacturers must designate a Swiss Authorised Representative
to export their products to Switzerland, in compliance with the Medical Device Ordinance (MedDo).
The adaptation of the Swiss medical device law is occurring in coordination with the transition periods in the EU. Manufacturers should be aware that the Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) will most likely not be updated by 26 May 2021. To prepare, manufacturers must designate an importer and a Swiss authorised representative from to supply devices to Switzerland.
According to SR812.213 (MepV) from 01. July 2020 entering into force 26. May 2021 Art. 104a the following transition period for a manufacturer which is located in the EU or EER or for a foreign manufacturer with an EU REP shall name for all products placed on the Swiss market after 26. May 2021 a Swiss AR:
- December 31st, 2021: Class III and class IIb and active implantable medical devices:
- March 31nd, 2022: Non-implantable products class IIb and IIa31.
- July 2022: Class I products, systems & procedure packs.