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2025

The COMET Project : Manufacturing commutable calibrators and quality control materials for standardisation and post-market surveillance of IVD tests

According to the in vitro diagnostic regulation (IVDR) EU/2017/746, the metrological traceability of values assigned to calibrators and/or control materials shall be assured through suitable reference measurement procedures (RMPs) and/or suitable Certified Reference Materials (CRMs) of a higher metrological order. Due...

V. Delatour, Amandine Boeuf, Chiara Giangrande et al. · 0 citations
Review 2025

The European Metrology Network TraceLabMed : coordinating activities of European NMIs/DIs and calibration laboratories in the field of laboratory Medicine

A coherent strategy for a joint European response to the need for establishing and verifying results metrological traceability in accordance with the IVD Regulation (EU) 2017/746 is created.

V. Delatour, G. O'Connor, Rainer Stosch et al. · 0 citations

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