Switzerland Update

An update posted on the Kofam portal on March 10, 2022, informs users of the change in legal requirements for clinical trials with in-vitro diagnostic products (IVDs) in Switzerland.

Clinical trials using IVDs, a special sub-group of medical devices, were regulated in the Clinical Trials Ordinance, (ClinO).  In the process of adapting the Swiss legislation to the new EU Medical Device Regulation (MDR) and the new EU regulation on IVDs (EU-IVDR), clinical research with IVDs in Switzerland will now also be regulated in the Ordinance on clinical trials with medical devices (ClinO-MD).

The changes would be effective from 26 May 2022, the same time as EU-IVDR.  From this date, the Clinical Trials Ordinance (ClinO) will only contain provisions for clinical trials with medicinal products, transplant products and transplantation, and other clinical trials.

Until the amended ClinO-MD comes into force, further information for applicants will be updated on the Kofam website, in a timely manner.

More information can be found here.