Exemption authorisations for non-conforming medical devices

Medical devices that are placed on the market or put into service in Switzerland must meet the requirements of the Medical Devices Ordinance (MedDO; SR 812.213) or the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219), respectively.

According to Art. 22 para. 1 and 2 MedDO / Art. 18 para 1 and 2 IvDO it is permissible in exceptional cases to place a non-conforming medical device on the market and to use it.

Further information is contained in the following information sheet: