swissdamed – swiss database on medical devices
swissdamed
swissdamed – swiss database on medical devices – is a database operated by Swissmedic for registering economic operators and medical devices (including in vitro diagnostic medical devices) and comprises an “Actors module” and a “UDI Devices module”.
Through its search function, swissdamed offers healthcare professionals and the public access to information about the medical devices and in vitro diagnostic medical devices placed on the market in Switzerland and about the economic operators (manufacturers, authorised representatives, importers), thereby contributing considerably to transparency.
swissdamed consists of two modules: the “Actors module” and the “UDI Devices” module. In order to preserve maximum equivalence between the Swiss and EU regulations and minimise the cost for economic operators, swissdamed resembles the corresponding modules of the European database EUDAMED.
swissdamed modules
- Actors module: Since August 2024, this module is being used for the registration of economic operators
- UDI Devices module: Go-live in several stages:
- Since August 2025, it has been possible to register devices, systems and procedure packs on a voluntary basis.
- Since 1 July 2026, both devices and systems/procedure packs placed on the market in Switzerland must be registered. A transitional period for the registration will apply until 31 December 2026.
- Immediate registration without a transitional period applies with effect from 1 July 2026 for devices and systems/procedure packs for which a serious incident, field safety corrective action or trend must be reported to Swissmedic.
*This information describes the obligations and transitional provisions applicable to economic operators established in Switzerland and to devices that are placed on the market in Switzerland. Based on the Customs Treaty1 between Switzerland and Liechtenstein, the terms “established in Switzerland” and “on the market in Switzerland” refer to the common market of Switzerland/Liechtenstein (customs union) if the devices are placed on the market on the basis of MedDO / IvDO2.
1 Treaty between Switzerland and Liechtenstein on the Accession of the Principality of Liechtenstein to the Swiss Customs Area (SR 0.631.112.514)
2 Due to the EEA agreement and the Liechtenstein-Switzerland customs treaty, two legal systems apply in parallel to medical devices in Liechtenstein. Medical devices can either be placed on the market based on MDR/IVDR or on MedDO/IvDO. The Switzerland/Liechtenstein common market relates only to placing on the market according to MedDO/IvDO. A placement on the market in Switzerland according to MDR/IVDR only is not contemplated.
