EU Reference Laboratories for Class D IVDs
With the implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746), the regulatory landscape for in vitro diagnostic devices (IVDs) in Europe has undergone significant changes. One of the most important new elements for manufacturers of high-risk (Class D) IVDs is the involvement of EU Reference Laboratories (EURLs) according to Article 100 of IVDR. Understanding the role and requirements associated with EURLs is essential for a successful conformity assessment and market access.
What are EU Reference Laboratories?
EURLs are independent laboratories designated by the European Commission that act in the public interest and support the implementation of the IVDR, specifically for Class D IVDs. Their primary role is to provide additional scrutiny and verification of the performance of Class D IVDs, as claimed by the manufacturer as well as compliance with the common specifications (CS). In addition, they perform batch testing to ensure ongoing product quality and reliability for both pre- and post-CE-marking.
Currently available EURLs
To date, the European Commission has designated EURLs for a total of six categories of Class D IVDs. In December 2025, two new categories were added: Class D devices for detecting parasite infection markers and devices for detection of blood grouping markers. The EURLs for parasites and blood grouping are expected to begin conformity assessment activities on May 1, 2026. The following table provides an overview of the currently designated EURLs and their respective scopes:
| Designated EU reference laboratory | Scope of designation Class D devices intended for detection or quantification of markers of: |
|---|---|
| Source: EU Commission (https://health.ec.europa.eu/medical-devices-vitro-diagnostics/eu-reference-laboratories-eurls_en, last checked April 21 2026) | |
| Consortium managed by Servicio Madrileño de Salud (SERMAS), Spain and composed of: Hospital General Universitario Gregorio Marañón, Spain Hospital Universitario la Paz, Spain Hospital Universitario Ramón y Cajal, Spain |
Herpes virus infection Infection with bacterial agents |
| Consulting Químico Sanitario SLU (CQS), Spain | Herpes virus infection Infection with bacterial agents Parasite infection Blood grouping markers |
| EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut (PEI-IVD), Germany | Hepatitis or retrovirus infection Respiratory virus infection Blood grouping markers |
| Instituto de Salud Carlos III (ISCIII), Spain | Hepatitis or retrovirus infection Herpes virus infection Infection with bacterial agents Parasite infection |
| RISE Research Institutes of Sweden AB (RISE), Sweden | Respiratory virus infection Blood grouping markers |
According to Regulation (EU) 2017/746, the EURLs should operate as a network to coordinate and harmonize their working methods.
Apart from the categories mentioned above, no EU Reference Laboratories have yet been designated for the categories “detection or quantification of markers of arbovirus infection” and “detection or quantification of markers of infection with hemorrhagic fever viruses or other biosafety level 4 viruses”. In the current 2025–2026 call for applications by the European Commission, laboratories were able to submit their applications to their respective Member State until 15 February 2026. It therefore remains to be seen which additional EURLs will be designated in the near future.
Key Functions of EURLs
- Verification of Performance: EURLs are responsible for verifying the performance claimed by the manufacturer as well as compliance with the applicable common specifications
- Batch Testing: For certain Class D IVDs, EURLs may be involved in batch testing to ensure ongoing product quality and consistency, as outlined in Article 48(5) and Annex IX, Section 4.9 of the IVDR
- Expertise and Guidance: EURLs provide scientific advice and guidance to Notified Bodies and Competent Authorities, contributing to a harmonized approach to the assessment of high-risk IVDs across the EU
When is EURL Involvement Required?
EURL involvement is mandatory for all Class D IVDs, except for those for which no EURL has been designated (see Article 48(5) IVDR). The manufacturer, in collaboration with the Notified Body, must submit samples and relevant technical documentation to the EURL as part of the conformity assessment process. The EURL’s report is a critical component of the overall assessment and must be considered by the Notified Body before issuing the CE certificate.
Implications for Manufacturers
- Preparation of Documentation: Manufacturers must ensure that their technical documentation is comprehensive, up-to-date, and ready for EURL review. This includes detailed performance data, risk analysis, and evidence supporting the intended use, as required by Annex II and Annex XIII of the IVDR
- Sample Management: Timely provision of product samples for EURL testing is essential to avoid delays in the conformity assessment process
- Regulatory Strategy: Early engagement with regulatory experts and proactive planning for EURL requirements can streamline the path to CE marking and market entry
Conclusion
In conclusion, although the participation of EU Reference Laboratories introduces an extra step in the conformity assessment process, it also gives manufacturers the advantage of early, independent validation. This can enhance confidence in the product’s performance and, through scientific assessment, support a more predictable path to compliance.
