All terms
Metrological Traceability (IVDR)
Annex I Section 9.4 requirement that values assigned to calibrators and controls are traceable to higher-order reference materials or procedures.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed July 25, 2026
Definition
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. What the regulation says
IVDR Annex I Section 9.4 and ISO 17511:2020 together establish that manufacturers must document the calibration hierarchy from the customer sample up to a reference material or procedure of higher order, where such higher-order references exist.
What this means in practice
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.Related terms
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FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
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Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
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Primary references
3 sourcesLink health: 2 verified 1 unchecked· last checked 2026-06-20
EUR-Lex·1ISO·1FDA·1
- 1
Regulation (EU) 2017/746, Annex I Section 9.4VerifiedEUR-Lexeur-lex.europa.eu
- 2
ISO 17511:2020UncheckedISOiso.org
- 3
FDA - Medical DevicesVerifiedFDAfda.gov
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