The Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219) set out requirements and responsibilities for operators in the medical devices supply chain. The following Information sheet outlines the roles and obligations of the Swiss authorised representative, the importer and the distributor.
In September 2024, Swissmedic additionally drew the attention of all Swiss authorised representatives and importers registered with Swissmedic to the transitional provisions for legacy devices and asked them to verify the products with regard to this matter. The following letter was sent to all Swiss authorised representatives and importers registered with Swissmedic.