IVD Medical Devices
Definition
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.
Classification
IVDs are classified under separate rules from non-IVD devices (see IVD Classification Rules). The key risk driver is the impact of an incorrect result on patient health or public health.
Analytical performance requirements
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)
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 IVDs
IVDs for lay user use require validation with the intended user population and special attention to labelling clarity.
Post-market obligations
Same as other devices — 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)