Announcements on Clinical Trials with Medical Devices and Performance Studies with Vitro Diagnostic Medical Devices

13 April 2023 – the Swissmedic announced on submissions for combined trials with medical devices and vitro diagnostic medical devices.

Swissmedic has updated the guidance for the submission of combined trials, and for submissions for already authorized trials that are newly becoming combined trials. The corresponding information can be found in Annex A7 of the Swissmedic information sheets for combined trials of medicinal products and medical devices and for combined trials of medicinal products and companion diagnostics / IVDs.

Read more online 
Copyright Widler & Schiemann AG 2022. All Rights Reserved. /