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Swiss Product Registration

Medical devices (MD)

Registration and notification obligations will be run via Swissmedic, as Switzerland does not have access to EUDAMED.

Which devices should manufacturers notify on Swissmedic before placing them on the Swiss market?

  • Custom-made devices

Further amendments on product-specific registration are possible.

We register your devices with SwissMedic.

Medical devices are regulated in Switzerland under the Medical Device Ordinance, which, in many cases, refers to EU MDR.

In-vitro medical devices (IVD)

For the moment, the Medical Devices Ordinance of 17 October 2001 – IVDD applies to in vitro diagnostic medical devices on the Swiss market until a new law is published.

There is no need for additional labelling nor notification to Swissmedic of IVDs that were previously notified to an EU/EAA Competent Authority and feature a person that placed them on the EU/EEA market.

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