As already reported in our news of 28 May 2021, a total revision of the Medical Devices Ordinance MepV was carried out in Switzerland in response to the European Medical Device Regulation (EU MDR). As a result of the correction, a revision of the MRA (Mutual Recognition Agreement) between Switzerland and the EU also became necessary. Negotiations have currently been broken off.
The agreement was supposed to ensure joint monitoring as well as uninhibited market access for both sides. As long as the MRA is not implemented, Swissmedic has no access to the central European database for medical devices (EUDAMED).
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