IVD Classification Rules
In vitro diagnostic (IVD) devices have separate classification rules from non-IVD devices. The key driver of IVD classification is the risk of harm from an incorrect test result.
Key classification factors for IVDs
| Factor | Description |
|---|---|
| Seriousness of the condition | Life-threatening vs. non-serious conditions |
| Impact of false positive/negative | What happens to the patient if the result is wrong |
| Public health impact | Whether false results could affect population health |
| Intended user | Laboratory professional vs. lay user (point-of-care, home-use) |
IVD classes
Class I IVD
Lowest risk. Incorrect results have minimal impact on patient health.
Examples: general chemistry analysers for non-critical analytes, non-sterile laboratory consumables, collection tubes for general testing.
Class II IVD
Low to moderate risk. Incorrect results may cause harm but are generally not life-threatening.
Examples: thyroid function tests, cholesterol/lipid tests, PSA tests, HbA1c tests, urine pregnancy tests (some configurations), haematology analysers.
Class III IVD
Moderate to high risk. Incorrect results may cause serious patient harm.
Examples: tumour markers, drug monitoring assays, prenatal screening tests, microbiological culture identification systems.
Class IV IVD
Highest risk. Incorrect results may directly cause death or have significant public health impact.
Examples:
- HIV antibody/antigen tests
- Hepatitis B and C tests
- Blood grouping and compatibility testing
- Nucleic acid tests for blood-borne pathogens
Point-of-care and home-use IVDs
IVDs intended for use outside a professional laboratory — including point-of-care (POC) tests and home-use self-tests — may be classified one class higher than the same test when performed in a laboratory, to account for the additional risks of:
- Use by untrained lay users
- Potential for misinterpretation of results
- Environmental variation in test conditions
Companion diagnostics (CDx)
A companion diagnostic — an IVD that is essential for the safe and effective use of a specific therapeutic product — may require coordinated review with the associated drug or biologic. See Combination Products.
Legislative source: Medical Devices Regulations, SOR/98-282, Schedule 2, Rules for IVD devices; s 2 (definition of "in vitro diagnostic device")