Whilst not a part of the European Union (EU), Switzerland is nevertheless closely aligned with Europe when it comes to its medical device regulations. As such, the application of the EU Medical Device Regulation (MDR) on 26 May 2021 has led to several changes in how Switzerland regulates its devices.
Medical devices in Switzerland are regulated by the Medical Devices Ordinance (MedDO) which has been significantly revised in light of the MDR with the updated Swiss legislation coming into force at the same time as the MDR. In addition, this date has seen the introduction of ClinO-MD, the regulation on clinical trials of medical devices.
The Mutual Recognition Agreement (MRA) is an agreement between Switzerland and the EU that allows for bilateral trade in numerous sectors including medical devices. The MRA provisions cover the mutual recognition of conformity assessment results, the absence of the need for an authorised representative and the alignment of technical regulations. A deal has not been reached on the Institutional Framework Agreement (another EU-Swiss agreement) and the MRA can’t be updated as a result. Consequently, temporary transitional provisions have been included in the amended MedDO (agreed as of 19 May 2021) so that in the absence of an updated MRA, the application of the MDR does not impact the continued supply of safe and effect devices to the Swiss population.
The implementation of the MDR also affects combination products (medicinal products with a medical device component) in Switzerland. Any applications for a combination product that do not bear a CE mark must now demonstrate that the medical device component satisfies the relevant basic safety and performance requirements set out in Annex I of the MDR. Furthermore, for integral medical device products without a CE certificate, a “Notified Body Opinion” must be submitted.