IVD Medical Devices
Definitionā
An in vitro diagnostic (IVD) device is a medical device used to perform tests on specimens (blood, urine, tissue) taken from the human body to provide information for diagnostic, monitoring, or prognostic purposes.
IVDs are classified using a separate classification framework from non-IVD devices (based on IMDRF guidance; see IVD Classification Rules). The primary risk driver for IVD classification is the potential clinical impact of an incorrect test result on individual patient health or public health outcomes.
Analytical performance requirementsā
All IVDs must demonstrate acceptable analytical performance:
| Parameter | Definition |
|---|---|
| Sensitivity (analytical) | Lowest detectable analyte concentration (LoD) |
| Specificity | Ability to measure only the target analyte |
| Accuracy | Closeness of results to true values |
| Precision | Reproducibility (repeatability and reproducibility) |
| Linearity | Range over which performance is accurate |
| Interference | Effect of interfering substances |
Clinical performance (Class III and IV)ā
Higher-class IVDs require clinical validation:
| Parameter | Definition |
|---|---|
| Diagnostic sensitivity | True positive rate |
| Diagnostic specificity | True negative rate |
| PPV / NPV | Predictive values in target population |
Point-of-care and home-use IVDsā
IVDs for lay user use require validation with the intended user population and special attention to labelling clarity.
Post-market obligationsā
Same as other devices ā complaint handling, mandatory problem reporting, recalls, and PMS.
Legislative source: Medical Devices Regulations, SOR/98-282, Schedule 2 (IVD rules); Schedule 1 (S&E requirements)
Analytical performance requirementsā
"Reference Materials and Controls\n\nIVD manufacturers must provide:\nā¢ Calibrators and quality control materials of defined composition and traceability\nā¢ Reference materials with documented values and uncertainty\nā¢ Stability data for calibrators and controls under stated storage conditions\nā¢ Information on calibration frequency and validity periods\nReferences materials should be traceable to international standards or recognized reference materials where available (e.g., ISO 17043 accredited providers)."
See also: IVD Classification Rules