In April 2022, Swissmedic started design work on the “swissdamed” database. Swissdamed stands for “Swiss Database on Medical Devices”.
Swissdamed will provide a realistic view of the life cycle of medical devices available in Switzerland. The database will integrate various IT systems which can be used to gather and process information about medical devices and the companies concerned (e.g. manufacturers). Like EUDAMED, swissdamed thereby aims to increase overall transparency, in particular by improving access to information by the public and by healthcare professionals.
Swissdamed will consist of two interconnected modules and a public website. Medical devices and economic operators will be registered on it. As the primary objective is to ensure equivalence between Swiss and EU regulations, swissdamed’s structure will be similar to the corresponding EUDAMED modules. It will be possible to register medical devices by mass upload.
Economic operators who register with Swissmedic before swissdamed becomes available, and therefore already have a Swiss Single Registration Number (CHRN), will not need to register again; they will simply have to check their data once these have been imported into the new system.
Swissdamed will be rolled out in three releases. The first release will cover the registration of economic operators and the second release will enable registration of medical devices. In the third and final release, additional functions will be added to the modules already implemented. Swissmedic will involve selected economic operators in the realisation phase.
All relevant specifications / additional information will be published on this page.
Registration on swissdamed will only become compulsory when the relevant amendments are made to the MedDO / IvDO. Until the ordinances are amended, devices can be registered on the swissdamed platform on a voluntary basis.