It has now been six months since the Swiss Federal Council and the EU Commission published that they cannot come to terms on a new Agreement, resulting in Switzerland becoming a Third Country as it relates to medical devices.
Has anything changed since then?
Unfortunately, there is not much to report. While the general understanding is that Switzerland believes access to the EU market is important, we have not seen anything concrete released that either the Swiss Federal Council or the EU Commission is pursuing new discussions with any haste.
This means that the current situation continues onward: non-Swiss manufacturers need a Swiss Authorized Representative and Swiss Importer to place medical devices onto the Swiss market. And Swiss manufacturers need an EU Authorized Representative and EU Importer to place devices onto the EU.
As there is no change to the status, the following deadlines continue to apply:
Appoint a Swiss representative (CH-REP), notify Swissmedic by the following timeframes and then add the CH-REP information to device labeling:
- 31 December 2021: AIMD/Class III/Class IIb implantable devices
- 31 March 2022: Class IIb non-implantable/Class IIa devices
- 31 July 2022: Class I devices/Systems and Procedure Packs
What about the IVDR?
While elements of the IVDR have been postponed (note: the EU Commission’s proposal is still pending with EU Parliament and Council), manufacturers of Class A self-certified in vitro diagnostic devices must comply with the IVDR by its date of application (DOA): 26 May 2022. Further, legacy devices with IVDD CE Marking, must comply with some aspects of the IVDR on the DOA, such as post-market surveillance, vigilance and registration of economic operators and devices.
Presuming no update to the Switzerland-EU MRA occurs in the meantime, then Switzerland will also become a third country as it relates to the IVDR on its DOA.
Thus far, Swissmedic has not advised on how to proceed under the IVDR. We’ll continue to keep you updated as new information becomes available.