Notification of devitalised human tissue

In Switzerland (and in contrast to the EU), classical and active implantable medical devices that are derived from or incorporate devitalised human tissue are deemed to be medical devices and are subject to mandatory notification under Art. 6, para.3 MedDO.

The following Information sheet provides further details on this subject:
The following notification form must be submitted to Swissmedic:
Please use the following form to report changes to devices that are already notified with Swissmedic:

Organs, tissues or cells of human or animal origin and products obtained from them (transplant products) which contain living cells and are intended for transplantation to humans are subject to the Transplantation Act (SR 810.21 Federal Act on the Transplantation of Organs, Tissues and Cells). These products are subject to notification and authorisation requirements, which can be found via the following links:

For transplant products:
For organs, tissues or cells of human or animal origin:
https://www.swissmedic.ch/content/swissmedic/en/home/medical-devices/market-access/notification-of-devitalised-human-tissue.html