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, have significant public health impact, or are critical to the diagnosis or monitoring of life-threatening conditions.
Examples:
- HIV antibody and antigen (also known as fourth-generation tests) 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")