MRA Impact on Market Access
When CE Marking Is Sufficient
When MRA Chapter 4 is fully operational:
- CE-marked devices compliant with EU MDR/IVDR can generally be placed on the Swiss market with simplified DAPI notification (not full registration) for Class I devices; Class IIa and above still require full DAPI registration even with MRA operational status
- EU NB certificates are recognised by Swissmedic without separate technical review
- Technical documentation is not separately re-evaluated by Swissmedic
When Separate Swiss Registration Is Required
When MRA Chapter 4 is not fully operational:
- Full DAPI registration is required for Class IIa, IIb, III and IVD List A/B/Self-test
- Class I devices: DAPI notification within 30 days (same as when MRA is operational)
- EU MDR/IVDR NB certificates and DoC are used as the conformity evidence within the DAPI registration
Always Required — Regardless of MRA Status
| Obligation | MRA Operational | MRA Not Operational |
|---|---|---|
| CH REP appointment | ✓ Required | ✓ Required |
| DAPI notification/registration | ✓ Simplified | ✓ Full registration |
| Swiss labelling (DE/FR/IT) | ✓ Required | ✓ Required |
| Vigilance reporting to Swissmedic | ✓ Required | ✓ Required |
| FSCA notification to Swissmedic | ✓ Required | ✓ Required |
Current MRA Status
caution
Always verify the current MRA Chapter 4 operational status before planning your Swiss market access timeline. See MRA Status Updates and contact Swissmedic or SECO directly.
Disclaimer
AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.
MRA Chapter 4 operational status should be verified within 30 days of commencing Swiss market access planning, as status changes impact registration timeline and may require either simplified notification or full registration.