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 |
Official Sources
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IVDO and MedDO are parallel and mutually exclusive ordinances.
IVDO requirements align closely with EU IVDR 2017/746 in scope, classification, and technical requirements. In-vitro diagnostic devices (IVDs) placed on the Swiss market must comply with IVDO; devices CE-marked under EU IVDR can generally access the Swiss market if IVDO requirements are met, subject to the current status of the CH–EU MRA Chapter 4. For transitional provisions and timelines for devices previously authorised under older Swiss IVD regulations, consult IVDO Chapter 10 and Swissmedic guidance.