From 26.05.2021 onwards, the new Regulation (EU) 2017/745 on medical devices will be fully applicable within the European Union. Switzerland is endeavouring to incorporate these requirements into Swiss legislation. This also includes the need for Swiss manufacturers, European authorised representatives and importers to register in the European database on medical devices (Eudamed). Once the registration has been validated by Swissmedic, Eudamed will assign a Single Registration Number (SRN) to the economic operator.
A collection of the most common questions and answers can be found in the following FAQ: