Authorisations for non-conforming medical devices

Medical devices that are placed on the market in Switzerland must have undergone a conformity assessment procedure during which the conformity with the essential safety and performance requirements is checked.

According to Art. 9 para. 4 and para. 5, respectively, of the Medical Devices Ordinance (MedDO; SR 812.213), it is permissible in exceptional cases to place a non-conforming medical device on the market and to put it into service.

Further information is contained in the following information sheet:

https://www.swissmedic.ch/content/swissmedic/en/home/medical-devices/market-access/authorisations-for-non-conforming-medical-devices.html