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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