Swissmedic
Swiss Agency for Therapeutic Products
Switzerland
Last reviewed 2026-06-21
Swissmedic regulates medical devices in Switzerland under the revised Medical Devices Ordinance (MedDO), which is largely aligned with EU MDR. Switzerland recognizes EU CE certificates for most device classes, simplifying market access for manufacturers already compliant with EU MDR.
DEVICE CLASSES
Class I, IIa, IIb, III
APPROVAL PATHWAY
EU CE recognition / Swiss conformity assessment
KEY REGULATORY FUNCTIONS
- ▸MedDO compliance oversight
- ▸Recognition of EU CE certificates
- ▸Swiss market surveillance
- ▸MDSAP participation
OFFICIAL WEBSITE
https://www.swissmedic.ch →§ FAQ
Does Switzerland accept CE marking for medical devices?
Switzerland recognizes EU CE certificates for most medical device classes under the Mutual Recognition Agreement (MRA) with the EU, which was updated to reflect the EU MDR transition. However, manufacturers still need to register their devices with Swissmedic and comply with the Swiss Medical Devices Ordinance (MedDO), which is largely aligned with EU MDR.
MedFlux monitors Swissmedic regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.
MONITOR {abbr} FREE →