Medical Device Registration in
Ministry of Health
Medical Device Regulation
EU Medical Device Regulation (MDR) 2017/745
German, French, Italian and Romansh
Class I, IIa, IIb and III
- Determine the device classification
- Appoint Authorized Representative and Notified Body
- Class I device can be Self-Certified. QMS necessary but Notified Body intervention is not required.
- For other classes, prepare a CE Technical File
- Obtain and register UDI in EUDAMED.
- Technical File should be audited by Notified Body.
- Once approved, prepare a Declaration of Conformity.
- The device can now be marketed in Switzerland
- CE Certificate
- Technical File
- Declaration of Conformity
- Clinical Evaluation Report (CER)
- Risk Management File
- QMS certificate
- Label, IFU and User Manual
Serious public health threats – 2 day
Death or serious health deterioration – 10 days
Other serious incidents – 15 days
- Swiss manufacturers and authorized representatives shall register all medical devices in the Medical Device Database before they are placed on the market. If the manufacturer is not based in Switzerland, their products may only be placed on the market if they have authorized a person based in Switzerland. The mandate must be agreed in writing.
- Labels and IFUs must be drafted in at least two of
Switzerland’s official languages (official languages are German, French and Italian).