According to article 47, In-vitro Diagnostic Devices or IVDs are classified as A, B, C and D, considering their intended purpose and inherent risks.
Class D (High personal risk, High public health risk)
Examples: Blood grouping ABO, Rhesus (including RHW1), Kell, Kidd and Duffy systems, CHAGAS, Syphilis (used for screening of blood donations), Hepatitis B and C etc.
Class C (High personal risk, Moderate to low public health risk)
Examples: Genetic tests, Companion diagnostics, Blood gas analyzers, Caner markers, Rubella, Neonatal screening for metabolic disorders etc.
Class B (Moderate to low personal risk, Low public health risk)
Examples: Thyroid function tests, Infertility assays, Clinical Chemistry
Class A (Low personal risk, Low public health risk)
Instruments, Specimen receptacles, Wash buffers etc.