Metrological Traceability for In Vitro Diagnostic Medical Devices Survey

Accurate, informative, and comparable biomarker measurements from commercial in vitro diagnostic (IVD) tests are essential for sound medical decision-making. In accordance with the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the metrological traceability of values assigned to calibrators and/or control materials must be ensured through appropriate reference measurement procedures (RMPs) and/or certified reference materials (CRMs) of higher metrological order. Despite…