EU Notified Bodies for the Swiss Market
Overview
Switzerland has no Swiss-designated notified bodies. All NB-assessed conformity assessment uses EU-designated NBs (under EU MDR/IVDR). The EU NB certificate forms the basis for Swiss market access, subject to MRA status.
Practical Workflow
- Engage EU NB with scope covering your device class (verify on NANDO)
- Complete EU MDR/IVDR conformity assessment (Annex IX, X, or XI)
- Receive EU NB certificates (QMS certificate + type/design examination certificate where applicable)
- Issue Declaration of Conformity referencing MedDO compliance
- Register in DAPI via CH REP (full registration or simplified notification depending on MRA status)
Swissmedic does not separately review the NB's technical documentation assessment.
MRA Impact
| MRA Status | Effect on Registration |
|---|---|
| Chapter 4 operational | CE-marked devices: simplified DAPI notification generally sufficient |
| Chapter 4 not fully operational | Full DAPI registration required for all classes; EU NB certificate is the evidentiary basis |
See MRA with EU — Current Status.
Official Sources
Disclaimer
AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.