Switzerland is now a "Third Country" for medical devices!!
MDSS CH GmbH is established.
In the context of aligning Swiss medical devices legislation to the new EU Medical Device Regulations MDR, the MRA (Mutual Recognition Agreement) needed to be updated so that barrier-free market access and joint surveillance could be ensured.
The lack of an updated MRA affected the mutual market access to – and trading of – medical devices, coordinated market surveillance activities and the sharing of information between authorities or the mutual recognition of certificates of conformity.
In summary, this means that since 26 May 2021, with the full application of the Medical Device Regulation MDR (EU) 2017/745 and in the absence of an institutional agreement reached, Switzerland is officially considered a “Third Country” for Europe. If the Manufacturer is based in an EU or EEA (European Economic Area) State or has mandated a person based in an EU or EEA State, it must designate a Swiss Authorised Representative for all devices that have been placed on the market after the May 26, 2021, within the following deadlines (Art. 51 paragraph 1):
- Class III, Class IIb implantable medical devices and active implantable medical devices - 31.12.2021
- Class IIb non-implantable medical devices and Class IIa medical devices - 31.03.2022
- Class I medical devices - 31.07.2022
The labelling is linked to the designation of the authorised representative. These provisions apply both to MDD/AIMDD and MDR devices.
Here is the link to Swiss Medtech https://www.swiss-medtech.ch/en/news/mdr-portal.