MDR entry into force: situation in Switzerland

The Medical Device Regulation (MDR) is about to apply in the European Union, starting on 26 May 2021. Since Switzerland is not a member state, this regulation does not apply in the country. Find here a summary of what this means for the time being in the regulatory environment.

Since Switzerland is not a member state, the European regulatory requirements do not apply to Swiss medical devices, which makes imports and exports between those two locations complicated. Furthermore, this implies a loss of attractiveness for Switzerland as a MedTech location and a loss of medical devices for Swiss patients.

However, a Mutual Recognition Agreement (MRA) could have been signed to encourage greater harmonisation of compliance standards between the EU and Switzerland. As no one has been signed (but could be in one or two years), the situation calls for an own Swiss regulation. Thus an amendment of the Swiss medical device ordonnance (Contingency MedDo) has been prepared and will come into force on the day when MDR will do, so on 26 May 2021. As of this day, the Swiss medTech industry will be considered as a third country. Just like in the UK because of the Brexit, this implies important changes and issues to consider for the medical device industry. Based on a Swiss Medtech paper, we sum up here the main points to consider:

• Import/Export:

  • Swiss manufacturers must appoint an EU Authorised Representative (EAR) to export medical devices to the EU.
  • Swiss distributors and importers must appoint a Swiss Authorised Representative (Swiss AR) to import medical devices into Switzerland.

• MDD products:

  • Negotiations are still underway regarding the mutual market access for MDD products:
    • No AR would be needed to transfer MDD products from Switzerland to the EU,  and conversely from the EU to Switzerland.
    • The transitional period until May 2024 for MDD products of Swiss manufacturers might apply.
  • MDD products that were made available on the EU market before 26 May 2021 will continue to be distributed until May 2025, without having to designate an EAR.

• Transitional periods (for the labeling and the appointment of a Swiss AR (given in the provisional Medical Devices Ordinance):

  • Until December 31, 2021: Class III devices, Class IIb implantable devices, active implantable devices.

  • Until March 31, 2022: Class IIb non-implantable devices, Class IIa devices.

  • By July 31, 2022: Class I devices, systems and procedure pack (SPP)