Do all Class D devices require EU Reference Laboratory involvement?

EURL involvement applies only where the Commission has designated a laboratory for that specific device type or analyte category, which as of the first designations in 2023 covers high-risk transmissible-agent categories such as HIV and hepatitis. Class D devices in categories without a designated EURL follow the standard Annex IX conformity assessment without this additional layer.

How is the EURL's role different from the notified body's role?

The notified body assesses the full technical documentation and quality management system against IVDR requirements, while the EURL provides an independent scientific verification of analytical and clinical performance claims and Common Specifications compliance specifically for in-scope Class D devices. The EURL's output feeds into, but does not replace, the notified body's overall conformity assessment decision.

What should manufacturers plan for when an EURL is in scope for their device?

Manufacturers should build EURL review timelines into their certification project plan early, since EURL verification and, where applicable, ongoing batch testing add lead time beyond a standard Annex IX assessment. Engaging with the designated EURL's published sample and documentation requirements before submission reduces the risk of review delays.

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RegulatoryRegulated Pathways Global MarketsEURL

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 the regulation says

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), adopted on 5 April 2017 and generally applicable from 26 May 2022, establishes the EURL framework principally in Article 100. The European Commission may designate laboratories for specific devices, categories or groups of devices, or specific hazards associated with them. Designated laboratories must meet requirements covering expertise, resources, equipment, independence and confidentiality. Their tasks include scientific and technical assistance to the Commission, Member States and notified bodies, alongside contributions to testing methods, common specifications and standards. For MedTech manufacturers of Class D devices, Article 48(5) requires the notified body to request verification from an EURL where one has been designated for the relevant scope. This covers the manufacturer’s claimed performance and compliance with applicable common specifications, or other solutions ensuring an equivalent level of safety and performance. Annex IX, Section 4.9, addresses this assessment and the laboratory’s scientific opinion; Section 4.12 provides for EURL testing within batch verification arrangements. EURLs support, rather than replace, notified bodies: their scientific findings inform conformity assessment, while certification remains the notified body’s responsibility.

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.

Examples

An EURL specialized in HIV detection performs batch testing on a manufacturer's new HIV diagnostic kit, verifying its performance against established common specifications before it can be certified for market.
During the conformity assessment of a novel blood-screening IVD for a highly infectious pathogen, an EURL provides a scientific opinion on the device's technical documentation to the notified body.
A manufacturer developing a Class D device for hepatitis C virus detection must submit samples to the designated EURL for independent verification of performance parameters and adherence to regulatory requirements.

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.

Frequently asked questions

For Class D devices where an EURL has been designated for the relevant analyte category, the EURL independently verifies the performance claimed by the manufacturer and confirms compliance with applicable Common Specifications, and it can contribute a scientific opinion the notified body must consider during conformity assessment. Without EURL verification where required, the notified body cannot issue the certificate.

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Acronym: EURL
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Updated: 7/25/2026

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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

Watch out: 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.

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