The Mutual Recognition Agreement (MRA) between the EU and Switzerland was not updated in May 2021. As a result, cooperation between the Swiss and EU authorities on medical devices has been suspended. Switzerland is treated as a third country in respect of medical devices (MDR products) and In-vitro-Diagnostic Devices (IVDR-products).

Consequently, the Swiss market surveillance authority Swissmedic no longer has access to EUDAMED and market surveillance data from the EU.

The Swiss Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO) therefore sets out additional measures to ensure that Switzerland is able to monitor foreign medical devices within Switzerland. The requirements in this regard are equivalent to those of the EU Regulations on medical devices (MDR) and In-vitro-Diagnostic Device Regulation (IVDR). Amongst other things, the Ordinance stipulates the appointment of an Authorised Representative in Switzerland and an appropriate labelling of the imported devices.

If the device manufacturer does not have its registered place of business in Switzerland, its devices may only be made available to the Swiss market once an Authorised Representative domiciled in Switzerland has been designated (CH-Rep)