Directives of European Union IVD MD serve as regulation for introducing the diagnostics on the common market. First aim of these Directives is achieving the acceptable level of trueness in routine measurements in laboratory medicine. Trueness of routine result is basic condition for effective using of the laboratory examinations in diagnostic and therapeutic processes. Creation and implementation of international reference measurement systems is the main tool for realisation of traceability of measurement. Only if working calibrators’ values are traceable to reference procedures and materials, the trueness of measurement can be assured on the required level. Only manufacturers produced such working calibrators, it means IVD manufacturers should be presented on the market and in our laboratories. We introduce important international standards of traceability and reference necessary for IVD MD. We also introduce the survey on the international metrological institutions, realised the reference activities. Complexity of this problemis emphasised. Last but not least there are mentioned relationships among metrology, production and routine measurements and requirements of users on the producers based on the point of view the IVD MD directives.

        Key words: traceability, reference measurement systems, IVD MD, calibration, trueness, metrology.