In vitro diagnostic (IVD) medical devices - Clinical performance studies: Expected changes in the legal requirements and BASEC
On May 26, 2022, the In Vitro Diagnostic Medical Device Regulation (IVDR at EU level) and in Switzerland the revised Ordinance on clinical trials with medical devices (ClinO-MD) will come into force. Accordingly, new requirements will be placed on IVD performance studies.
Such studies will no longer be regulated by the Clinical Trials Ordinance (ClinO), but the authorisation granted under the previous regulations by Swissmedic and the ethics committee remain valid. For these performance studies no authorisation under the new regulations (ClinO-MD) must be obtained.
As of May 26, 2022, applications to the ethics commissions of IVD performance studies are made exclusively with the BASEC submission form «RESEARCH PROJECT APPLICATION FORM FOR MEDICAL DEVICES and IN VITRO DIAGNOSTIC DEVICES».
Applications of IVD performance studies submitted before May 26, 2022 through the BASEC submission form «RESEARCH PROJECT APPLICATION FORM» will remain on that form and not moved to the above-mentioned submission form. However, the new regulations apply when it comes to future notifications, changes and reporting in the course of conducting a trial approved before May 26, 2022. The findings of all clinical trials with IVDs completed after May 26, 2022 must now be published in a register.
Swissmedic and swissethics will publish on May 26, an updated guidance document on safety reporting and a new dedicated form for the reporting of SAEs and device deficiencies occurring during the course of a IVD performance study to Swissmedic (for category C studies) and to the ethics committees (for category A and C performance studies).
The FOPH's Coordination Office for Human Research (kofam) provides further information on its page «Clinical trials with medical devices, including in-vitro diagnostic products: changes in the legal requirements».