Medical Device Swiss market - new situation

The new European medical device regulation came into force on 26 May 2021. Parallel, a complete revision of the Medical Devices Regulation MepV was carried out in Switzerland, under the responsibility of the Swiss BAG (Federal Office of Public Health). In context of the alignment of the MepV and the KlinV-Mep with the new EU regulations MDR and IVDR on medical devices, it was also necessary to update the existing MRA (Mutual Recognition Agreement) between Switzerland and the EU. This agreement ensures a barrier-free market access and joint implementation. The MRA is, in turn, part of an "overall package" of an institutional framework agreement (Insta), which has not yet been conclusively agreed on. On the contrary: Switzerland has meanwhile broken off negotiations with the EU and described them as "having failed".

A mutual recognition agreement in the area of conformity assessment (MRA) is the most important document to establish the principles necessary to connect Swiss and EU markets. MRA’s are intended to reduce time and costs associated with the access to foreign markets for numerous categories of industrial goods including medical devices.

The information from the EU Commission included the following points:

  • New medical devices under the MDR (incl. class I products):
    • Swiss medical device manufacturers must appoint an authorized representative in the EU.
  • Existing certificates issued by a Notified Body based in Switzerland:
    • CE mark issued in Switzerland are no longer be recognized as valid in the EU.
  • Existing certificates issued by Notified Bodies located in the EU:
    • Will continue to be recognized by the EU
  • Access for foreign manufacturers to the Swiss market:
    • The requirements of the Swiss Medical Devices Ordinance (MepDO, as per 26 May 2021) apply.
    • Includes recognition of all existing certificates and transition periods staggered according to respective risk class (7, 10, 14 months) for the designation of an authorized representative in Switzerland.

Since 26 May 2021, Switzerland is officially considered a “Third Country” for Europe. This means that Swiss Manufacturers must appoint a European Authorized Representative to export their devices to Europe. At the same time, European Manufacturers must designate a Swiss Authorized Representative to export their products to Switzerland, in compliance with the Medical Device Ordinance (MedDo).

Any possible further developments regarding the EU-Switzerland MRA for medical devices will be communicated in due course. We are waiting for some news soon!

Joint to our LinkedIn and stay tuned!

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