EU Notified Bodies for Switzerland
Overview
Switzerland has no Swiss-designated notified bodies for medical devices. Manufacturers use EU-designated NBs (under EU MDR/IVDR) for all conformity assessment procedures requiring NB involvement. The EU NB certificate forms the basis for Swiss market access, subject to the MRA.
Practical Workflow
- Engage an EU-designated NB with scope covering your device class (check NANDO)
- Complete conformity assessment under EU MDR/IVDR (Annex IX, X, or XI)
- Receive EU NB certificates (QMS certificate + EU type examination/design examination certificate where applicable)
- Issue Declaration of Conformity referencing MedDO compliance
- Register in DAPI (where required, depending on MRA status)
Swissmedic does not re-review the NB's technical documentation assessment.
MRA Impact
| MRA Status | Effect |
|---|---|
| MRA Chapter 4 operational | CE-marked devices generally access Swiss market without separate full registration (DAPI notification still required) |
| MRA Chapter 4 not fully operational | All devices require DAPI registration regardless of CE status; EU NB certificate is the evidentiary basis |
See MRA with EU — Current Status.
Official Sources
Disclaimer
AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.