IVD

In Vitro Diagnostic (IVD) devices are medical devices used to examine specimens derived from the human body (blood, urine, tissue) to provide information for diagnosis, monitoring, or screening of diseases, conditions, or health states.

What qualifies as an IVD:
- Tests performed on samples taken from the body
- Provides diagnostic, monitoring, or screening information
- Includes reagents, calibrators, control materials
- Includes instruments and specimen receptacles

Common IVD examples:
- Blood glucose monitors
- Pregnancy tests
- COVID-19 tests
- Cholesterol tests
- Blood typing reagents
- Genetic tests

IVD regulation by region:

USA (FDA):
- Regulated under 21 CFR Part 862-892
- Same pathways: 510(k), De Novo, PMA
- Laboratory Developed Tests (LDTs) under separate oversight

EU (IVDR 2017/746):
- Separate regulation from EU MDR
- Applied since May 26, 2022
- Classes A, B, C, D (D highest risk)
- Stricter than previous IVDD

Key differences from other medical devices:
- Often consumable/disposable components
- Require performance evaluation instead of clinical investigation
- Reference to "gold standard" testing methods
- Specific stability and shelf-life requirements

IVD vs IVD Medical Device:
All IVDs are medical devices, but not all medical devices are IVDs. The distinction matters for regulatory pathway selection.