Measuring / Diagnostic Function Validation
MDR Reference: Annex I, GSPR 15; Classification Rule 10 (Class I(m))
Service Item ID: mdr_sec06_measuring
Applicability: Devices with a measuring function, diagnostic devices
Overview
Devices with a measuring or diagnostic function must demonstrate the accuracy, precision, and reliability of their measurement capabilities. MDR GSPR 15 establishes specific requirements, and Rule 10 may trigger Class I(m) classification for measuring devices.
Key Requirements
- Accuracy and precision: Documented and validated against reference methods
- Calibration: Traceable to national or international metrological standards
- Measurement limits: Defined and validated (range, resolution, linearity)
- Metrological traceability: Per ISO/IEC 17025 or equivalent
- Clinical performance: Sensitivity, specificity, positive/negative predictive values (for diagnostics)
Key Deliverables
| Document | Description |
|---|---|
| Measurement Performance Specification | Accuracy, precision, range, resolution |
| Calibration Protocol & Report | Metrological traceability evidence |
| Analytical Performance Report | Repeatability, reproducibility, linearity, interference |
| Clinical Performance Data | Sensitivity, specificity (if applicable) |
| Labelling of Measurement Accuracy | Per MDR Annex I GSPR 15 requirements |
GSPR Mapping
| GSPR | Requirement |
|---|---|
| 15.1 | Measuring devices designed for accuracy and stability |
| 15.2 | Measurement values expressed in legal units |
| 15.3 | Accuracy limits indicated |
Related Topics
- Design V&V -- Measurement validation as part of design V&V
- Software V&V -- Software algorithms performing measurements