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EU MDR and its impact on Swiss – EU relations

The agreement between Switzerland and the European Union EU) on mutual recognition in relation to conformity assessment (MRA) of medical devices that aimed to facilitate the trade ended in May 2021. The interruption of the MRA has had many consequences. Switzerland has been considered a third country for medical devices as of May 26, 2021, and a valid MRA could have granted a smooth alignment of the Swiss medical legislation with the new EU Regulations for medical devices (MDR 2017/745).  While for In vitro diagnostic medical devices (IVDs), the MRA chapter remains valid until the IVDR date of application – May 26, 2022. Without an update to the MRA, IVD manufacturers will face the same situation as their medical device counterparts. Together with the obligation to mandate a Swiss Authorised Representative, manufacturers of medical devices who want to sell in Switzerland must respect other obligations, such as a registration to Swissmedic, and further labelling requirements.

Last year, the Swiss Federal Council has given foreign manufacturers of medical devices additional time to mandate a Swiss Authorised Representative (deadlines can be found here):

  • for class III devices, class Iib implantable devices, and all active implantable devices, the deadline to appoint a Swiss Authorised Representative was December 31, 2021.
  • for Class IIb and Class IIa medical devices, the deadline is March 31, 2022, and for Class I devices & systems and procedure packs July 31, 2022.

For a manufacturer of medical devices that wants to place products on the Swiss market, among others, the following steps needs to be considered:

  • appointment of a Swiss authorised representative (mandatory for any non-Swiss manufacturer);
  • registration and notification via Swissmedic (Switzerland is not using EUDAMED);
  • registration for economic operators in three months following the placing of a device on the Swiss market.

For IVDs, the final Swiss Ordinance on IVDs has not yet been published. Nevertheless, Swiss Medtech recently shared a timeline for designation of a Swiss Authorized Representative for:

  • Class D devices by December 31, 2022
  • Class C and B devices by March 31, 2023
  • Class A devices by July 31, 2023

The above is still subject to Federal Council decision.