According to the EU Parliament, the postponement aims to give national authorities, notified bodies, manufacturers and others time to prioritise the fight against the coronavirus pandemic.
We now wish to provide you with information about the consequences for the Swiss medical technology industry as follows:
- The new date of application of the MDR is the 26th of May 2021.
- Up until the 26th of May 2021, medical devices may be placed on the market within the EU single market under the current European and national regulatory framework.
- The present Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) also falls within the current regulatory framework.
- Consequently, MDD products and MDR products are therefore able to be placed on the market within the EU single market up until the 26th of May 2021 as before, without non-member country requirements having to be fulfilled.
- Under the current regulatory framework, EC certificates and EU certifications issued by Swiss conformity assessment bodies will remain in full force and effect until at least the 26th of May 2021.
- The public announcement on the functioning of the central database Eudamed (Art. 34 MDR) is scheduled to be made on the 26th of March 2021, meaning that Eudamed will not be operational until the 26th of May 2021 at the earliest.
Swiss Medtech recommends that Swiss companies take into account the fact that the MRA might not have been updated in a year's time either. Should this be the case, all products (MDD and MDR) would have to satisfy non-member country requirements from the 26th of May 2021 onwards. The Page 2 of 2 association recommends using the thirteen months until the new date of application to prepare in the best way possible for such an eventuality.