Swissdamed: Swiss Database on Medical Devices

Swissmedic has officially announced the launch of their registration database “Swissdamed” which is set to go live in 2023.  

Swissdamed will be utilized in a similar fashion as EUDAMED to register medical device and IVD manufacturers, along with their products. Additionally, it will be utilized by to register other economic operators including authorized representatives, distributors, and importers.  

Here are the main highlights of the announcement from Swissmedic: 

• • It will comprise two linked modules and also a public website.
  • Economic operators who register with Swissmedic before Swissdamed becomes available will not have to reregister as everything will be rolled into the new system.  
  • The “go-live” date is planned for 2023 and will be rolled out in three phases:

1. 1. 1. 1. Economic Operator Registration module
         2. Medical Device & IVD Registration module
         3. Additional functionality for the above modules

• • Due to the ongoing effort to make Swiss and EU regulations equivalent, the Swissdamed modules will be similar to the corresponding EUDAMED modules.

The full announcement and details can be found here on Swissmedic’s website. 

MedEnvoy Global will continue to communicate and detail the updates on Swissdamed- the Swiss database on medical devices.