What exactly does the EU Reference Laboratory check during batch verification?

Under Article 100(2)(a), the EURL verifies by laboratory testing that the batch meets the manufacturer's declared performance and conforms with the applicable Common Specifications or the alternative solution the manufacturer has chosen. This is an independent, batch-by-batch confirmation, not a one-time design verification.

How should manufacturers plan production release timelines around this requirement?

Because EU RL testing sits on the critical path to batch release, manufacturers need to build the laboratory's turnaround time into their production and distribution planning and establish clear service-level expectations with the designated EURL well before commercial launch. Underestimating this lead time is a common cause of unplanned stock delays for high-risk Class D assays.

Is Class D batch verification unique to IVDR, or does it have a precedent?

It closely mirrors the strict pre-release controls historically applied to blood-typing and infectious-disease screening assays before IVDR, extending that model formally across the IVDR's Class D category through the EU Reference Laboratory network. It is one of the strictest release controls in EU device regulation, exceeding equivalent MDR requirements for high-risk medical devices.

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Class D Batch Verification (IVDR)

Pre-release testing of every manufactured batch of Class D IVDs by an EU Reference Laboratory, where designated.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed July 25, 2026

Definition

Article 48(5) and Article 100 require that, for Class D devices where Common Specifications or, in their absence, harmonised standards exist and an EU Reference Laboratory has been designated for the device type, the manufacturer must have each batch tested by the EU RL before release. The EU RL verifies that the batch meets the applicable CS or the manufacturer's declared performance.

What the regulation says

Article 100(2)(a) tasks EU Reference Laboratories with verifying, by laboratory testing, the performance claimed by manufacturers and the conformity of devices with applicable CS or other solutions chosen by manufacturers.

What this means in practice

This is one of the strictest controls in EU device regulation and mirrors requirements historically used for blood-typing and infectious-disease screening. Manufacturers must build EU RL turnaround time into release planning and negotiate service-level expectations early.

Examples

A manufacturer of a novel HIV diagnostic IVD for blood screening must send a sample from every production batch to the designated EU Reference Laboratory for verification before it can be released to the market.
A company developing a hepatitis B virus detection IVD, which falls under Class D and has an assigned EU Reference Laboratory, schedules batch submissions to the EU RL into their supply chain and release planning.
A manufacturer designing a Class D IVD for detecting specific pathogens in donor blood ensures their quality system includes provisions for preparing and submitting batch samples to the EU RL for independent performance verification.

Common pitfalls

•Manufacturers may underestimate the time and resources required for EU Reference Laboratory (EU RL) testing, leading to significant delays in product release if not planned effectively.
•Assuming that internal quality control testing alone is sufficient for Class D devices, neglecting the mandatory independent verification by an EU RL for designated device types.
•Failure to engage with designated EU RLs early in the development and regulatory planning process to understand their specific requirements and turnaround times.

Frequently asked questions

Only where Common Specifications or, in their absence, harmonised standards exist for that device type and an EU Reference Laboratory has been designated for it. Article 48(5) and Article 100 make batch verification conditional on both a designated EURL and an applicable performance standard being in place, not a universal Class D requirement.

Grouped by theme

Editor's picks

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Common Specifications (IVDR)(CS)

Technical or clinical requirements adopted by Commission implementing act that manufacturers must comply with unless a demonstrably equivalent alternative is used.

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EU In Vitro Diagnostic Regulation(IVDR)

Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.

Regulatory

EU Reference Laboratory (EURL)(EURL)

Laboratory designated by the Commission to verify performance of Class D IVDs and provide scientific advice.

Regulatory

IVDR Risk Classes A–D

EU IVDR's risk-based classification: Class A (lowest) to Class D (highest).

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Pre-release testing of every manufactured batch of Class D IVDs by an EU Reference Laboratory, where designated.

·This is one of the strictest controls in EU device regulation and mirrors requirements historically used for blood-typing and infectious-disease screening.
·Manufacturers must build EU RL turnaround time into release planning and negotiate service-level expectations early.
·The EU RL verifies that the batch meets the applicable CS or the manufacturer's declared performance.

Remember this

Watch out: Manufacturers may underestimate the time and resources required for EU Reference Laboratory (EU RL) testing, leading to significant delays in product release if not planned effectively.

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