IFCC Standardization of HbA1c

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Overview | The IFCC Reference System | Traceability and the EU Directive | The IFCC and NGSP

Traceability and the EU Directive

The EU directive states that "The traceability of values assigned to calibrators and/or control materials must be assured through available reference measurement procedures and/or available reference materials of a higher order". Therefore, for all products sold in Europe, manufacturers must make their products results "traceable" to the IFCC Reference Method.

Reference: Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices Official Journal of the European Communities 1998; 331:1–3

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