Exemptions for non-conforming medical devices

An exemption permits non-conforming medical devices to be placed on the market for use by individual patients.
When can an exemption for medical devices be requested? Humanitarian exemptions in individual cases: Under Article 9 paragraph 4 of the Medical Devices Ordinance (SR 812.213), the exemption option exists for individual patients with life-threatening conditions or permanently impaired physiological functions that cannot be treated in any other way and which do not meet the inclusion criteria of ongoing clinical trials. Applications for exemptions must be submitted to Swissmedic as required.

Further information can be found here:

  • Information sheet on exemptions (application submission, processing times, conditions for granting, fees):

  • Application submission form:

The procedure for making submissions has been revised. The completed form and attachments now have to be submitted in electronic format via the Swissmedic’s “emessage” portal:

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