Glossary

Certified reference methods [MDCG 2022-2]

MDCG

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.

 

[Definition according to MDCG 2022-2 No. 4, also corresponds to WHO TGS-8 definition: Quality control for in vitro diagnostic medical devices for WHO prequalification]