Access the Swiss market with requirements aligned to the EU, and some that are not.
Swiss law mirrors the MDR and IVDR, but without an updated mutual recognition agreement with the EU, manufacturers face Swiss-specific obligations.
Key facts
Pathways
- Devices with valid EU certificates are recognised under Swiss law
- Swiss Authorised Representative (CH-REP) required for manufacturers outside Switzerland
- Economic operator and device registration with Swissmedic
- Importer obligations, including importer details on labelling
What you will need
- EU technical documentation and certificates
- CH-REP mandate and CH-REP details on labelling
- Swiss registration data
- Product information in the official languages required
Sequence and decision points
- 01Confirm EU statusValid CE certificate and EU documentation in place.
- 02Appoint a CH-REPWritten mandate with a Swiss-based representative.
- 03RegisterEconomic operators and devices registered with Swissmedic.
- 04LabelCH-REP and importer details added to labelling.
- 05MonitorVigilance reporting to Swissmedic.
QMS requirements mirror the MDR and IVDR; EU certificates are relied on.
A CH-REP is mandatory for manufacturers outside Switzerland, including those based in the EU. Importers must also meet Swiss obligations.
Where MedoQi does not hold this role, we work with your appointed representative or a qualified partner.
Registration with Swissmedic is administrative. The main lead times are appointing a CH-REP and updating labelling.
After market entry
- Serious incident reporting to Swissmedic
- Field safety corrective actions
- PMS aligned with MDR and IVDR requirements
How we help
- Swiss market entry planning
- CH-REP coordination
- Labelling updates for Switzerland
- Swissmedic registration support
- Vigilance coordination
Delivered through our model: assess, validate, remediate, submit, maintain. How we work
Common questions about Switzerland
Summary information for orientation. Requirements depend on intended use, classification and device characteristics, and change over time.
Is our CE certificate valid in Switzerland?
Yes. Swiss law recognises EU certificates, but you still need a CH-REP, Swiss registration and Swiss labelling details.
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.