Swissmedic edited its “swissdamed – Swiss Database on Medical Devices” webpage to remove the 2023 ‘go-live’ date. 

The current release dates for swissdamed, as well overview of the June 2023 pilot testing, are available: HERE

Further, the swissdamed User Guide (with screenshots) has been published, if you would like a sneak peek at the system: HERE

Background

Swissdamed is the new registration database being developed by Swissmedic, due to it no longer having Competent Authority level access to EUDAMED.

Now that Switzerland is cut out of the EU system, it will create its own central database. It will consist of an Actors and UDI/Devices registration module and will be modeled on EUDAMED.  

The Update

Swissmedic advised that the pilot testing conducted in June 2023 was successful, and the feedback will be incorporated into the system prior to its ‘go-live’.

The new dates for swissdamed are:

• • Registration of companies and economic operators – ACT module (available from autumn 2023)
  • swissdamed – freely accessible platform (available from autumn 2023)
  • Registration of devices – UDI module (available from summer 2024)

It is structured around two interconnected modules, for which only registered users can access. It also includes a freely accessible search function.

What’s Next?

The swissdamed Actor module will become available for new registrations in autumn 2023. The UDI/Device registration module will follow in summer 2024.

Swissmedic will roll all Economic Operators* who already have a Swiss Single Registration Number (CHRN) into the new Actor module.

NOTE: until the Swiss Medical Device Ordinance (MedDO) and IVD Ordinance (IvDO) are updated, use of swissdamed will be voluntary.

Casus will provide updates as they become available, including timing on when you need to take action, i.e., when use of swissdamed becomes mandatory.

*Swiss Manufacturers, System/Procedure Pack Producers, Authorized Representatives, and Importers.