Authorizations for Non-conforming Medical Devices

On 1 August 2020 the Swissmedic published the information sheet about the authorizations 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.

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