IVDO Classification Rules 1–7
The Four IVD Categories
List A — Highest Risk Highest risk to public health or individual patients. Require NB involvement for both QMS audit and technical documentation assessment. Examples: HIV 1/2, HBsAg, ABO/Rhesus blood grouping, anti-erythrocyte antibodies, NAAT tests for HIV/HCV/HBV.
List B — Moderate Risk Moderate public health impact. Require NB QMS audit. Examples: rubella, toxoplasma, CMV, PSA, ANA, TSH, SARS-CoV-2 antigen.
Self-Test Devices Intended for use by lay persons testing themselves. Require NB involvement (including usability assessment). Examples: blood glucose self-testing monitors, pregnancy tests, COVID-19 self-tests, cholesterol test kits.
General IVDs All IVDs not in List A, B, or Self-test. Self-declaration only. Examples: general chemistry analysers without specific List A/B analyte claims, specimen collection devices.
Rules 1–7
- Rule 1 — IVDs for List A purposes → List A
- Rule 2 — IVDs for List B purposes → List B
- Rule 3 — Companion diagnostics → List A or B (based on associated medicine risk)
- Rule 4 — Near-patient testing → at least List B if not already List A
- Rule 5 — Self-testing devices → Self-test
- Rule 6 — All other IVDs → General
- Rule 7 — Software IVDs → assigned to highest applicable category based on output use
Official Sources
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