Certified reference methods

A reference method sits at the top of the traceability chain and is used to assign values to materials. When one exists for an analyte, reviewers expect the IVD's traceability to link to it.

Measurement method which has been certified to show appropriate trueness and precision for its intended purpose and has been officially defined as reference method by a competent body.

MDCG 2022-2, Section 4, Definitions (source: WHO TGS-8)