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MedDO vs IVDO — Which Applies?

Overview​

Switzerland has two separate, mutually exclusive ordinances for medical devices:

  • MedDO (SR 812.213) — medical devices and accessories; mirrors EU MDR 2017/745
  • IVDO (SR 812.219) — in vitro diagnostic medical devices; mirrors EU IVDR 2017/746

A product is governed by one or the other — never both simultaneously.

MedDO — Medical Device Ordinance​

Applies to instruments, apparatus, implants, software, and other articles with a medical intended purpose achieved by physical, mechanical, or chemical means. Also applies to products without a medical purpose listed in MedDO Annex XVI (e.g. coloured contact lenses). Uses four classes: Class I, IIa, IIb, III.

IVDO — IVD Ordinance​

Applies to reagents, kits, instruments, software, and systems intended for in vitro examination of specimens derived from the human body (blood, urine, tissue, organ donations). Uses four categories: List A (highest risk), List B, Self-test, General IVD.

Decision Flow​

  1. Intended for in vitro examination of human specimens? → IVDO
  2. Achieves purpose by pharmacological/immunological/metabolic means? → Likely a medicinal product
  3. Has a medical intended purpose achieved by physical/mechanical/chemical means? → MedDO
  4. Listed in MedDO Annex XVI (non-medical purpose)? → MedDO
  5. None of the above → probably not a medical device

Combination and Borderline Cases​

Some products have characteristics of both. See Borderline & Combination Products. In ambiguous cases, Swissmedic can provide a borderline opinion.

Official Sources​

Disclaimer

Content is AI-assisted and intended as a navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.