New measures to be applied
Given the lack of update of the MRA, Switzerland has put in place measures to mitigate the negative effects of this development:
– the lack of access by Swiss authorities to the centralized European database for medical devices (Eudamed 3),
– the lack of collaboration in the field of market surveillance.
These measures include, for example, the staggering of deadlines for the appointment of a representative (“CH-REP“), the obligation for economic operators to register with Swissmedic, the reporting of serious incidents to Swissmedic, and the recognition in Switzerland of EU conformity certificates.