A new Mutual Recognition Agreement (MRA) between Switzerland end the European Union including MDR/IVDR remains outstanding. Thus, as of the Date of Application (DoA) of the MDR, 26 May 2021, Switzerland will be considered a third country under the MDR for both MDR compliant devices as well as all MDD compliant devices, even if they have a valid Notified Body certificate.
At the end of March 2021, the EU Commission announced that the transitional period (Grace Period included in the MDR) until 2024 would also apply, under certain conditions, to MDD products from Swiss manufacturers. May 12th 2021, Swiss MedTech issued a statement in which it highlighted that the ongoing negotiations between Switzerland and the EU for a transitional solution for MDD products have not yet been concluded and have not yet resulted in any agreement. Swiss MedTech urges all Swiss medtech industry to be aware of the fact that only those MDD products placed on the EU market before 26 May 2021 are sure to benefit from the transition period until May 2024.
All Swiss manufacturers and distributors of medical devices must realise that as of 26 May 2021 they will have to comply with the requirements of a third country for all medical devices (MDR and MDD) if the MRA is not completed or no political agreement has been obtained. This essentially involves the appointment of a European Authorized Representative for all medical devices exported to the EU and a Swiss Authorized Representative for all medical devices imported into Switzerland.
The Federal Office of Public Health (FOPH) has prepared an amendment to the Medical Devices Ordinance (“Contingency MedDO”) as a precautionary measure, which will be put into force by the Federal Council on 26 May 2021 if the MRA has not been updated by that date. The Contingency MedDO provides transitional periods for the appointment of a Swiss representative, including corresponding labelling, staggered according to risk classes:
- Until 31 December 2021 for class III devices, class IIb implantable devices, and all active implantable devices.
- Until 31 March 2022 for non-implantable class IIb devices and class IIa devices.
- Until 31 July 2022 for Class I devices, systems and procedure packs.
This currently only applies to medical devices as the Date of Application of the IVDR is only 26 May 2022. If at that point in time the MRA is still not amended and in place then the same scenario will unfold for IVDs.
What does this mean to you?
If you are a Swiss based medical device manufacturer you should now be ready to meet these new third country requirements or have a plan in place to ensure that you can make use of the MDR transitional provisions by placing devices on the EU market prior to the MDR DoA. If you are based outside of Switzerland and wish to continue placing medical devices on the Swiss market you should have set-up an agreement with a Swiss Representative.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.