News about GMP/cGMP

28.05.2021

Switzerland, EU-MDR und a missing MRA

Switzerland, EU-MDR und a missing MRA

The new European medical device regulation came into force on 26 May 2021. Parallel, a complete revision of the Medical Devices Regulation MepV was carried out in Switzerland, under the responsibility of the Swiss BAG (Federal Office of Public Health). In context of the alignment of the MepV and the KlinV-Mep with the new EU regulations MDR and IVDR on medical devices, it was also necessary to update the existing MRA (Mutual Recognition Agreement) between Switzerland and the EU. This agreement ensures barrier-free market access and joint implementation. The MRA is, in turn, part of an "overall package" of an institutional framework agreement (Insta), which has not yet been conclusively agreed on. On the contrary: Switzerland has meanwhile broken off negotiations with the EU and described them as "having failed".


This scenario has serious consequences:

Mutual market access and movement of good of medical devices, coordinated market surveillance activies and exchange of information between authorities or mutual recognition of certificates of conformity are affected by the pending update of the MRA agreement. Without an MRA update, Swissmedic will be denied access by the authorities to the central European database for medical devices (EUDAMED), which has been available since 1 December 2020. Swissmedic will be excluded from the working groups on the joint surveillance of new medical products and will not be able to access enforcement-relevant data.

What comes next?  

In preparation for a failed agreement, the Swiss Federal Council passed an amending decree to the MepV on 19 May 2021, to supplement the revised medical law. This defines varius measures and transitional periods to guarantee the supply of safe devices in Switzerland and to dampen the negative effects on market surveillance.The provisions allow, e.g., unilateral market acces for medical devices certified in the EU according to the new regulation and thus reduce supply disruptions in Switzerland. Since 26 May 2021, Swiss manufacturers must establish a socalled authorised representative for their products in the EU.

The Federal Council has set longer transition periods in some cases. These relate in particular to registration and notification obligations. Manufacturers, importers and authorised representatives must register with Swissmedic and receive a unique identification number (CHRN). This registration for a CHRN has already been prepared in advance.

Thus, there is hope that an agreement between Switzerland and the EU can still be achieved.


Source:

BAG Switzerland: News room


 

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