This document establishes requirements for an international harmonization protocol to achieve equivalent results across multiple in vitro diagnostic medical devices (IVD MDs) for the same measurand when no reference measurement procedures or certified reference materials exist. It defines the highest level of metrological traceability and can also be applied when existing reference materials or calibrators are not fit-for-purpose, such as when they lack commutability with human samples.

NOTE This document addresses one case of traceability of assigned and measured values described in 5.6 in ISO 17511:2020.