An update posted on the Kofam portal on May 27, 2022, informs users of the most important new developments and changes relating to clinical trials with in-vitro diagnostic products (IVDs) which are regulated by the Ordinance on Clinical Trials with Medical Devices (ClinO-MD) from May 26, 2022.
According to the update, in addition to the existing obligation to prospectively register clinical trials with IVDs, the results of trials with IVDs must now also be published in a trial registry. This also applies to clinical trials with IVDs already underway when the ClinO-MD entered into force on 26 May 2022. The updated ClinO-MD is also now available.
The update further informs users of the categorization of IVDs and classification of clinical trials regulated under ClinO-MD into clinical investigation and performance studies.
An online information event, to cover the new and changed requirements and clarify the specifications in Switzerland will be held on 3 November 2022. Participation is free of charge and individual presentations will be provided on the Swissmedic website in German, French, Italian, and English a few days before the event. The presentations during the event will be given in German and will be interpreted simultaneously into French. The event will not be recorded. The presentations can not be viewed at a later date.
More information can be found here.