Swissmedic: Standalone Regulations for In vitro Diagnostic Medical Devices

Concurrent with the application of the IVDR in the EU, the new Swiss regulation on in vitro diagnostic medical devices, IvDO, came into force on 26 May 2022. This is the first time since 2001 that the "third country rules" apply to IVDs in Switzerland, as they already do for all other medical devices for a year now (we reported). As of the same date, clinical trials with in vitro diagnostic medical devices are regulated in the Ordinance on Clinical Trials with Medical Devices (CTO-MedD) and no longer in the Ordinance on Clinical Trials (ClinO).

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