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Laboratory testing is at the heart of modern health care: an estimated 70% of medical decisions depend on in vitro diagnostics (IVDs). Benefits for patients, healthcare providers and the IVD industry are improved when robust and metrologically traceable IVDs are used to provide accurate test results irrespective of the laboratory, the IVD provider, or the instrumentation used for testing.
Metrological traceability of IVDs enhances validity of diagnosis, supports further treatment, and lowers the financial burden on healthcare systems by avoiding nonessential testing. Traceability is also an important aspect of regulatory schemes: IVD manufacturers need to comply with legal requirements for traceability to gain and maintain market access.
These requirements are defined in the regulation on in vitro diagnostic medical devices EU 2017/746 (IVDR) and include metrological traceability of calibrator and control material values along with testing of highrisk IVDs by EU reference laboratories. The European network on Traceability in Laboratory Medicine (TraceLabMed) was established to build a coordinated metrologybased quality infrastructure in an area that affects almost every European citizen.
For download: Overview of EMN TraceLabMed (PDF)