--- title: "EURL, EU Reference Laboratory (EURL) | MedTech Terms" description: "Laboratory designated by the Commission to verify performance of Class D IVDs and provide scientific advice. Plain-English Regulatory definition for MedTech tea" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr-eu-reference-laboratory#term", "name": "EU Reference Laboratory (EURL)", "alternateName": "EURL", "description": "Articles 100 to 102 of the IVDR provide for Commission-designated EURLs for specific analytes or classes of analytes. 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. EU Reference Laboratory (EURL) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)EURL # EU Reference Laboratory (EURL) Laboratory designated by the Commission to verify performance of Class D IVDs and provide scientific advice. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Articles 100 to 102 of the [IVDR](/terms/ivdr) provide for Commission-designated EURLs for specific analytes or classes of analytes. EURLs verify performance claimed by the manufacturer and compliance with [common specifications](/terms/common-specifications) for Class D devices, contribute scientific opinions during conformity assessment, and support notified bodies with expertise on high-risk categories such as blood-transmissible agents. ## What this means in practice For Class D devices in scope, EURL batch testing and performance verification are prerequisites to certification. The first EURLs were designated in 2023 for high-risk transmissible-agent categories. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. ](/terms/ivdr)[ Regulatory IVDR Risk Classes A–D EU IVDR's risk-based classification: Class A (lowest) to Class D (highest). ](/terms/ivdr-classes) ### 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 European Commission· 1 FDA· 1 1. [1 Regulation (EU) 2017/746, Articles 100 to 102 Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 2. [2 Commission designations of EURLs Unchecked European Commission health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector/new-regulations/eu-reference-laboratories-eurl_en) 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. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym EURL Sources 3 Updated 7/25/2026 [Compare with another term](/compare?a=ivdr-eu-reference-laboratory) Learn in 60 seconds Card Lesson Quiz Laboratory designated by the Commission to verify performance of Class D IVDs and provide scientific advice. - · For Class D devices in scope, EURL batch testing and performance verification are prerequisites to certification. - · The first EURLs were designated in 2023 for high-risk transmissible-agent categories. Remember this Laboratory designated by the Commission to verify performance of Class D IVDs and provide scientific advice. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [IVDR Risk Classes A–D ](/terms/ivdr-classes) You may also need Auto-suggested from Regulatory and shared keywords. - [IVDR Conformity Assessment Routes ](/terms/ivdr-conformity-assessment-routes) - [Class D Batch Verification (IVDR) ](/terms/ivdr-class-d-batch-verification) - [Notified Body Scrutiny (IVDR Class D) ](/terms/ivdr-notified-body-scrutiny) - [Common Specifications(CS) ](/terms/common-specifications) - [AI Act Conformity Assessment (Medical Devices) ](/terms/ai-act-conformity-assessment) - [CE Mark ](/terms/ce-mark) [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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