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.

Why it matters

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.

Common pitfalls

•Manufacturers may underestimate the time and resources required for EURL batch testing and performance verification, leading to delays in market access for Class D IVDs.
•Companies might not fully understand that EURL involvement is a mandatory prerequisite for certification of Class D devices within their scope, not just an optional step.
•There's a misconception that EURL approval replaces the need for comprehensive manufacturer-driven performance studies, whereas EURLs primarily verify claims against common specifications.

Sources

Regulation (EU) 2017/746, Articles 100 to 102 · EUR-Lex
MDCG endorsed guidance documents · European Commission
FDA - Medical Devices · FDA

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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