Metrological Traceability (IVDR)

BPG reference: Team-NB BPG-IVDR V2 (Metrological traceability, approx. pp. 21–22)

Checklist

• [ ] Explain how results are traceable to an appropriate reference (reference material, reference measurement procedure, or international convention)
• [ ] Calibrator value assignment and hierarchy documented
• [ ] Units/conversions consistent across IFU and performance evaluation
• [ ] Where no higher-order reference exists: describe the manufacturer’s internal reference system and maintenance
• [ ] Link to analytical performance (trueness/bias, commutability)
• [ ] If software/algorithms contribute to results: impact on traceability described

Related pages

• Stability
• Performance evaluation