--- title: "Metrological Traceability (IVDR), Definition | MedTech Terms" description: "Annex I Section 9.4 requirement that values assigned to calibrators and controls are traceable to higher-order reference materials or procedures." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr-metrological-traceability#term", "name": "Metrological Traceability (IVDR)", "description": "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. 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. Metrological Traceability (IVDR) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets) # 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 Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Annex I Section 9.4 of the [IVDR](/terms/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](/terms/ivd) calibrators, controls, and human samples. What the regulation says [IVDR](/terms/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 Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Analytical Performance (IVDR) The ability of an IVD to correctly detect or measure a particular analyte. ](/terms/ivdr-analytical-performance)[ Regulatory EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. ](/terms/ivdr) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory 510(k) Summary vs 510(k) Statement 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. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 2 verified 1 unchecked · last checked 2026-06-20 EUR-Lex· 1 ISO· 1 FDA· 1 1. [1 Regulation (EU) 2017/746, Annex I Section 9.4 Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 2. [2 ISO 17511:2020 Unchecked ISO iso.org ](https://www.iso.org/standard/69984.html) 3. [3 FDA - Medical Devices Verified FDA fda.gov ](https://www.fda.gov/medical-devices) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. 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On this term Category Regulatory Sources 3 Updated 7/25/2026 [Compare with another term](/compare?a=ivdr-metrological-traceability) Learn in 60 seconds Card Lesson Quiz Annex I Section 9.4 requirement that values assigned to calibrators and controls are traceable to higher-order reference materials or procedures. - · 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. - · ISO 17511:2020 is the harmonised standard describing traceability chains for IVD calibrators, controls, and human samples. Remember this IVDR Annex I Section 9. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [Analytical Performance (IVDR) ](/terms/ivdr-analytical-performance) You may also need Auto-suggested from Regulatory and shared keywords. - [IVDR Conformity Assessment Routes ](/terms/ivdr-conformity-assessment-routes) - [Clinical Performance (IVDR) ](/terms/ivdr-clinical-performance) - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) - [Summary of Safety and Performance (IVDR)(SSP) ](/terms/ivdr-summary-safety-performance) - [AI Act Conformity Assessment (Medical Devices) ](/terms/ai-act-conformity-assessment) - [AI Act Technical Documentation (Annex IV) ](/terms/ai-act-technical-documentation) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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