IVD Ordinance (IVDO)
Overview
The IVD Ordinance (Verordnung über In-vitro-Diagnostika, IVDO / SR 812.219) governs in vitro diagnostic medical devices in Switzerland. It mirrors EU IVDR 2017/746 in structure and technical requirements. IVDO and MedDO are parallel and mutually exclusive ordinances.
Structure
IVDO parallels MedDO in structure but applies IVD-specific definitions, classifications, and requirements. Key differences include:
- Classification system (List A, B, Self-test, General) instead of MedDO's four-class system
- Performance evaluation (Annex XIII) instead of clinical evaluation (Annex XIV)
- Performance studies requirements instead of clinical investigations
- IVD-specific GSPR requirements in Annex I (including analytical and clinical performance requirements)
Key Differences from MedDO
| Aspect | MedDO | IVDO |
|---|---|---|
| Classification | Class I, IIa, IIb, III | List A, B, Self-test, General |
| Clinical evidence | Clinical evaluation (CER) | Performance evaluation |
| PMCF equivalent | PMCF plan and report | PMPF plan and report |
| PSUR frequency | Annual (IIb/III) / biennial (IIa) | Annual (List A/B) / biennial |