swissdamed – swiss database on medical devices

swissdamed

swissdamed – the Swiss Database on Medical Devices – is a Swissmedic database for registering economic operators and medical devices, including in vitro diagnostic medical devices, on the Swiss market.

swissdamed aims to provide an overview of the medical devices, including in vitro diagnostic medical devices, available on the Swiss market and the economic operators responsible for them. The database gathers and publishes information about medical devices and the companies concerned (manufacturers, authorised representatives, importers).

swissdamed provides a publicly accessible website with a search function. It has been designed to give 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 responsible for them, and thereby increase 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 effort for economic operators, swissdamed has aligned its modules to the corresponding modules of the European database EUDAMED.

Since there is no interface between swissdamed and EUDAMED, Swissmedic cannot import or synchronise data from EUDAMED. Swiss manufacturers, persons who assemble systems and procedure packs, and authorised representatives must actively upload device data to swissdamed. Currently, an XML file in EUDAMED 'GET DEVICE' or 'POST DEVICE' format can be used for this purpose. Further upload methods, for example machine-to-machine, will be possible at a later date.

swissdamed modules

swissdamed Roadmap

For registered economic operators

  • 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. Devices, systems and procedure packs can be registered under the existing legislation (MedDO and IvDO). The registration of devices under the old legislation according to Art. 101 MedDO and Art. 82 IvDO (“legacy devices”), as well as Master UDI-DIs will be possible at a later date (before 1 July 2026).
    • On 1 July 2026, the registration obligation for devices and systems/procedure packs placed on the market in Switzerland will enter into force. A transitional period for the registration will apply until 31 December 2026.
    • Immediate registration without a transitional period will apply 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.

Publicly accessible website with a search function

  • Search for economic operators
  • Search for medical devices and in vitro diagnostic medical devices