Market access for medical devices and in vitro diagnostic medical devices
Manufacturers, authorized representatives, importers, distributors or heath institutions may only place medical devices and in vitro diagnostic medical devices (IVD) on the market, make them available on the market or put them into service when the applicable conformity assessment procedure has been successfully completed. This legal requirement also applies to medical devices and IVD that are given away free of charge, rented or used directly. Certain medical devices and IVD are associated with a duty to notify the Swiss Agency for Therapeutic Products. Such notifications according to Art. 18, 19, 53, 54, 103 and 108 MedDO of 1 July 2020 (Medical Devices Ordinance, SR 812.213), or Art 10, 46, 47 and 90 IvDO of 4 May 2022 (Ordinance on In Vitro Diagnostic Medical Devices, SR 812.219), will attract a fee of CHF 300.- per notification according to the Ordinance of the Swiss Agency for Therapeutic Products on its fees (GebV-Swissmedic, SR 812.214.5).