All terms
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 CyberLast reviewed July 25, 2026
Definition
Articles 100 to 102 of the 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 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
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510(k) Premarket Notification(510(k))
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
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.
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.
Regulatory
Abbreviated 510(k)
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
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Where this term appears across MedTech Terms.
Ecosystems (2)
Primary references
3 sourcesLink health: 2 verified 1 unchecked· last checked 2026-06-20
EUR-Lex·1European Commission·1FDA·1
- 1
Regulation (EU) 2017/746, Articles 100 to 102VerifiedEUR-Lexeur-lex.europa.eu
- 2
Commission designations of EURLsUncheckedEuropean Commissionhealth.ec.europa.eu
- 3
FDA - Medical DevicesVerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.