Mitteilungen über klinische Prüfungen mit Medizinprodukten und Leistungsstudien mit In-vitro-Diagnostika

Einreichungen bei kombinierten Versuchen


Announcements on clinical investigations with medical devices and interventional performance studies with IVD

Submissions for combined trials

Swissmedic has updated the guidance for the submission of combined trials, and for submissions for already authorised trials that are newly becoming combined trials.

You can find the corresponding information in Annex A7 of the Swissmedic information sheets BW600_00_015e_MB (for combined trials of medicinal products and medical devices) and BW600_00_016e_MB (for combined trials of medicinal products and companion diagnostics / IVDs).