Notification of custom-made devices

Custom-made devices

First placers on the market who are Swiss-domiciled manufacturers or authorised representatives must notify Swissmedic when they place custom-made classical or active implantable medical devices on the market for the first time. The legal basis for this requirement is Art. 6 of the Medical Devices Ordinance.

The following form should be used for this purpose:
https://www.swissmedic.ch/content/swissmedic/en/home/medizinprodukte/marktzugang/meldung-sonderanfertigungen.html