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; DAPI registration required |
| 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
AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.
Technical Documentation Sampling for Class IIa When Class IIa devices follow the Annex IX route, the NB may conduct sampling of technical documentation rather than full review of every device in a group. The extent of sampling depends on device family homogeneity, design similarity, and manufacturing processes. Manufacturers should be prepared to justify device grouping decisions and may be asked to provide full documentation for selected representatives.