On 4th of May 2022, the Federal Council adopted the new Ordinance on In vitro Diagnostic Medical Devices (IvDO) and the amendment to the Ordinance on Clinical Trials with Medical Devices (CTO-MedD). The aim of the new regulations is to improve patient safety by means of stricter requirements for conformity assessment and post-market surveillance. The new legal requirements enter into force on 26 May 2022, at the same time as the application of the IVDR in the EU. From 26 May 2022, clinical trials with in vitro diagnostic medical devices will be regulated in the CTO-MedD and no longer in the Ordinance on Clinical Trials (ClinO).
To avoid jeopardising a sufficient supply of medical devices to Switzerland, the Federal Council has set lengthy transitional periods, over one year for most devices, for designating the Swiss authorised representative (CH-REP). The transitional provisions also affect registration and reporting obligations in particular. 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 in vitro diagnostic medical devices 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 Swiss Agency for therapeutic products (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.
More information on the new Regulation is available on Swissmedic website – New regulations applicable to in vitro diagnostic medical devices as of 26 May 2022.