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Swissmedic’s approach to handling EC certificates for medical devices

After the publication of ANSM now Swissmedic published a procedure in order to give manufacturers located in Switzerland, whose Notified Body terminated his activities due to de-notification or other reasons, to continue under certain circumstances placing products on the market without having a certificate issued by the new Notified Body.

According to Swissmedic a European harmonized procedure has been agreed on end of October 2016. However, except from France and Switzerland, no other published procedure from other countries is known so far.

We recommend all manufacturers concerned to contact their Competent Authority in time.