EU IVDR EURLs Under Article 100: Designated Classes, Tasks and Fees

1. Key takeaways

European Reference Laboratories (EURLs) are designated by the Commission through implementing acts and carry out the ten tasks of Article 100(2)(a) to (j). Their core role for manufacturers is to verify, for Class D devices, the performance claimed by the manufacturer and compliance with applicable common specifications, and to carry out tests on samples or batches of devices produced. The designated categories have developed in two rounds: (EU) 2023/2713 (2023-12-05) designated 4 categories with 5 laboratories in total, taking on conformity assessment tasks from 2024-10-01; (EU) 2025/2526 (2025-12-16) added two categories, biomarkers of parasitic infections and blood group markers, applicable from 2026-05-01, and only to applications formally submitted by the manufacturer or the authorised representative to a notified body from that date.

For a Class D manufacturer, the EURL question is not optional reading but a scheduling input. Whether the product category has a designated EURL determines whether Article 48(5) verification is triggered, and the date on which the application is formally submitted determines whether the two newest categories apply to the project. EURL involvement also brings its own cost line, governed by a separate implementing act on fees, which must be budgeted separately from the notified body quotation.

2. Legal basis

The table below lists the primary legal sources on EURLs under Article 100.

3. Expert insights

Insight 1: the EURL is not an optional step but a category-triggered mandatory one.

The wording of Article 48(5) is that, for devices for which one or more EURLs have been designated under Article 100, the notified body carrying out the conformity assessment shall request one of them to verify the performance claimed by the manufacturer and compliance with the applicable common specifications, or with other solutions that ensure an equivalent level of safety and performance. The starting point of the analysis is therefore always the same question: is there a designated EURL for my product category? If yes, participation is compulsory and its cost and timeline must be absorbed into the project; if no, the layer simply does not exist for that device, and the notified body route runs alone.

Insight 2: the six designated categories already cover the main transfusion and infection risk classes of Class D.

According to the official Commission pages, the first four categories are hepatitis and retroviruses, herpes viruses, bacterial agents, and respiratory viruses causing life-threatening diseases; the two added categories are biomarkers of parasitic infections and blood group markers. The designated institutions are located in Germany (PEI-IVD), Spain (a consortium of ISCIII, SERMAS and CQS) and Sweden (RISE). Categories such as arboviruses have not yet been designated, because no suitable applications were received or the available capacities were insufficient. Manufacturers in non-designated categories should still track future calls, because a later designation changes their own compliance position.

Insight 3: the new categories have an application-date cut-off.

Article 2(3) of (EU) 2025/2526 makes clear that the performance verification task under Article 100(2)(a) applies to the newly designated laboratories only for devices for which the manufacturer or the authorised representative formally submitted the application for conformity assessment to a notified body, under the first subparagraph of Section 4.3 of Annex IX, from 2026-05-01. This cut-off line has real project value: an application formally submitted before that date stays outside the new categories, while one submitted after it must include the EURL layer. Manufacturers close to a filing date should therefore weigh the timing decision deliberately, including what an earlier filing does to the rest of the project plan.

Insight 4: EURL fees have their own implementing act and belong in the project budget.

Article 100(7) allows EURLs to charge fees for scientific and technical assistance or scientific opinions requested by notified bodies or Member States, in full or partial coverage of their costs, under conditions that must be predetermined and transparent; Article 100(8)(b) empowers the Commission to set the structure and level of fees by implementing act, currently (EU) 2022/945. A Class D project budget should therefore carry the EURL fee as a separate line item rather than folding it into the notified body quotation, and the charging basis should be checked against the implementing act before the application.

4. Practical recommendations

The following actions integrate EURL planning into a Class D project.

1. As the first project step, check whether the product category falls within the designated scope of (EU) 2023/2713 and (EU) 2025/2526.
2. If the product belongs to a new category, evaluate whether formally submitting the application before 2026-05-01 is feasible and what that decision does to the project timeline.
3. Confirm sample submission requirements with the notified body early: sample volumes, batches, condition, transport conditions and testing periods.
4. Carry the EURL fee as a separate budget line and check the charging basis against (EU) 2022/945.
5. Track future Commission calls for EURL designation, since categories not designated in the second round of applications may be added later.

5. Verification checklist

Confirm the following points on EURL applicability and preparation.

• □ Whether the product category has a designated EURL has been confirmed (6 categories designated)
• □ For new categories, the consequences of filing before or after 2026-05-01 have been evaluated
• □ Sample submission requirements (volumes, batches, condition, transport) have been confirmed with the notified body
• □ EURL fees have been budgeted separately in line with (EU) 2022/945
• □ Whether applicable common specifications exist has been confirmed (determines whether verification is against the CS or an equivalent solution)
• □ A regulatory tracking mechanism for EURL category extensions is in place

Regulatory information verified as of October 29, 2026.

GRZAN supports IVD manufacturers in the EU market with CE certification pathway and classification strategy under Regulation (EU) 2017/746. For Class D programmes we help you determine EURL applicability across the designated categories, plan application timing around the 2026-05-01 cut-off, prepare sample logistics and budget EURL fees under (EU) 2022/945. Contact us at info@grzanglobal.com to discuss your EU IVDR programme.