The new transitional periods of the EU are based on risk classes and extend in some cases into 2027. They also apply in the Swiss Ordinance. In addition, the IvDO provides further transitional periods and safeguards both to ensure the supply of IvDs and to mitigate the effects of the "third country rules". In particular, the provisions allow for the unilateral recognition of EU certificates of conformity. Supplementary requirements such as the registration of economic operators and the reporting of serious incidents to Swissmedic, as well as the establishment of a so-called Swiss authorised representative (CH-REP) for foreign manufacturers, help Swissmedic to maintain market surveillance despite being excluded from the network of EU authorities (we reported). A longer transitional period has also been set for the designation of a CH-REP. As Switzerland no longer has access to the European database EUDAMED, registration with Swissmedic is a must. Swissmedic is currently working on the conception of a Swiss database. It will register economic operators and medical devices. Due to the continued aim of equivalence between the regulations in Switzerland and the EU, the medical devices database should be similar to EUDAMED.

Source:

Swissmedic: IvDo (available in German, Italian and French)

Swissmedic: General communications