Annex I Section 9.4 of the IVDR requires that the metrological traceability of values assigned to calibrators and/or control materials is assured through available reference measurement procedures and/or available reference materials of a higher metrological order. ISO 17511:2020 is the harmonised standard describing traceability chains for IVD calibrators, controls, and human samples.

Why it matters

Traceability is what allows two different manufacturers' assays for, say, HbA1c or troponin to produce clinically comparable results. Notified bodies increasingly ask for explicit traceability diagrams and uncertainty budgets in Class C and D technical documentation.

Common pitfalls

•Mistaking 'traceability' for simply showing a measurement chain without formally establishing the metrological link to higher-order reference materials and uncertainty budgets. It's not enough to just state a reference material was used; the quantitative relationship must be proven.
•Failing to understand that metrological traceability is required not only for calibrators but also for control materials used in IVD assays, ensuring their assigned values are equally robust. Both are critical for accurate measurement and quality control.
•Assuming that using a certified reference material automatically fulfills all traceability requirements without evaluating the full chain and associated measurement uncertainties. Proper documentation and a clear traceability diagram are essential.

Sources

Regulation (EU) 2017/746, Annex I Section 9.4 · EUR-Lex
ISO 17511:2020 · ISO
FDA - Medical Devices · FDA

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