Swiss Database on Medical Devices
16 septembre 2022 – Since the agreement between the Swiss Confederation and the European Union on the mutual recognition of conformity assessments (MRA) has not been updated, the registration of economic operators and of medical devices and in vitro diagnostic medical devices is carried out directly by Swissmedic. Swissmedic began with the implementation of the “swissdamed” database in April 2022. Swissdamed stands for “Swiss Database on Medical Devices”. The registration will become compulsory with the relevant amendment to the Medical Devices Ordinance (MedDO, SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO, SR 812.219) which is planned for 2023.
For more information, see here.