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.

• Switzerland: Medical Devices Ordinance [MedDO]
• MDR: Regulation (EU) 2017/745 [EU MDR]
• Published guidance and helpful documents are available in MDlaw Library– Switzerland