Metrological traceability

For IVDs, the IVDR requires the values assigned to calibrators and control materials to be traceable to reference materials or procedures of a higher order. Without that chain, results from different laboratories and test versions cannot be compared reliably.

Property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty. The metrological traceability chain is a sequence of measurement standards and calibrations that is used to relate a measurement result to a reference.

MDCG 2022-2, Section 4, Definitions (source: VIM 3rd edition)