Conformity Assessment Overview
Overview
Conformity assessment is the structured process manufacturers follow to demonstrate device compliance with all MedDO/IVDO requirements. Lower-risk Class I devices use manufacturer self-declaration; higher-risk devices require EU-designated notified body (NB) involvement.
Routes by Device Class
| Device Class | Route |
|---|---|
| Class I (standard) | Annex IV self-declaration only |
| Class Im (measuring) | Annex IV + NB (metrology aspects) under Annex IX or XI |
| Class Is (sterile) | Annex IV + NB (sterility aspects) under Annex IX or XI |
| Class Ir (reusable surgical) | Annex IV + NB (reprocessing aspects) |
| Class IIa | Annex IV + Annex IX (QMS + tech doc sampling) or Annex X + XI |
| Class IIb | Annex IV + Annex IX (full QMS + tech doc) or Annex X + XI |
| Class III | Annex IV + Annex IX Chapter II (design examination) or Annex X + XI |
| IVD List A | Annex IX Chapter II + Chapter I, or Annex X + Annex IX Chapter I |
| IVD List B | Annex IX Chapter I, or Annex X + Annex XI |
| IVD Self-test | Annex IX + Chapter II, or Annex X + Annex XI |
| IVD General | Annex IV self-declaration |
Annex Summary
- Annex IV — Declaration of Conformity and self-declaration procedure
- Annex IX — QMS-based conformity assessment (Chapter I: QMS audit; Chapter II: technical documentation review for Class III/List A)
- Annex X — Type examination by NB on a representative sample
- Annex XI — Production conformity verification following Annex X
Official Sources
Disclaimer
AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.