New information on submitting vigilance reports for medical devices

Swissmedic has revised the information on submitting vigilance reports (incidents, trend reports and FSCA reports) for products according to the Medical Devices Ordinance (SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (SR 812.219).

Please note the following: If a manufacturer domiciled outside of Switzerland and Liechtenstein submits a vigilance report to Swissmedic, the responsible authorised representative (“CH-REP”) must be included in the e-mail distribution list.