Annual safety and general progress trial report for clinical trials with medical devices

05.05.2025

As announced on February 18 (see News 18.2.2025 below), swissethics is today publishing a new template for writing the annual safety and general progress trial report for clinical trials with medical devices. Swissmedic and swissethics have developed the template together. In accordance with article 35 ClinO-MD, the report must be submitted to the competent ethics committee. The reporting period for the first annual report starts with the approval of the clinical trial and ends after one full year. The report is submitted once a year for the entire duration of the clinical trial (Link).