The European Commission may designate EU reference laboratories (EURLs) for high-risk in vitro diagnostic medical devices (IVDs) according to Article 100 of Regulation (EU) 2017/746.
The EURLs have two main categories of tasks: advisory ones and those related to conformity assessment, particularly of the highest risk (class D devices).
For conformity assessment of class D devices, the EURLs will:
- verify the performance of class D devices and compliance with common specifications,
- perform batch testing of class D devices.
The European Commission may launch calls to Member States to submit applications for candidate EURLs. Following the assessment of compliance with criteria, the Commission can designate EURLs by implementing act.
The following implementing acts are relevant for EURLs in the field of IVDs:
- Commission Implementing Regulation (EU) 2022/944 on tasks and criteria for the EURLs
- Commission Implementing Regulation (EU) 2022/945 on fees that the EURLs may levy from notified bodies and Member States
Designated EURLs for Class D IVDs
To date, the European Commission has designated EURLs in six categories of Class D IVDs.
EURLs in four categories of Class D IVDs were designated in December 2023 by Commission Implementing Regulation (EU) 2023/2713. In December 2025, EURLs in two additional categories of Class D IVDs were designated by Commission Implementing Regulation (EU) 2025/2526.
| Designated EU reference laboratory | Scope of designation Class D devices intended for detection or quantification of markers of: |
|---|---|
Consortium managed by Servicio Madrileño de Salud (SERMAS), Spain and composed of: |
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| Consulting Químico Sanitario SLU (CQS), Spain |
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| EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut (PEI-IVD), Germany |
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| Instituto de Salud Carlos III (ISCIII), Spain |
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| RISE Research Institutes of Sweden AB (RISE), Sweden |
|
The EURLs in the categories of hepatitis or retroviruses, herpesviruses, bacterial agents, and respiratory viruses took up their tasks in the conformity assessment of devices on 1 October 2024.
The EURLs in the categories of parasites and blood grouping are expected to take up their tasks in the conformity assessment of devices on 1 May 2026.
Call for applications 2025-2026
In February 2025, the Commission, after consulting the Member States in the Medical Device Coordination Group, launched a call to Member States to submit further applications on behalf of their candidate laboratories for designation of EURLs.
This call is conducted in two waves:
1. First wave was open to applications in the following categories of class D devices:
- detection or quantification of markers of arbovirus infection
- detection or quantification of markers of parasite infection
- detection of blood grouping markers.
The selection procedure for this first wave of the call has been concluded.
The Commission reviewed the applications submitted by Member States based on the following elements specified in the call:
- the applicant laboratories must satisfy all the criteria, and
- the combined capacity of all compliant laboratories in a given category must cover the expected volume of requests for tasks related to market access of devices.
- 2 laboratories for detection or quantification of markers of parasite infection
- 3 laboratories detection of blood grouping markers.
4 laboratories were shortlisted for designation covering the following categories:
All laboratories to be designated for the new categories are already designated as EURLs for IVDs for other categories.
The laboratories were designated as EURLs by Commission Implementing Regulation (EU) 2025/2526.
For the arboviruses category, there were either no laboratories that satisfied the criteria or their combined capacity was insufficient to cover the expected volume of requests. Therefore, no EU reference laboratory will be designated for this category of devices in this wave.
2. The second wave is open for applications in any of the following 8 categories of class D devices:
- detection or quantification of markers of hepatitis or retrovirus infection
- detection or quantification of markers of herpesvirus infection
- detection or quantification of markers of infection with bacterial agents
- detection or quantification of markers of arbovirus infection
- detection or quantification of markers of respiratory virus infection
- detection or quantification of markers of infection with haemorrhagic fever viruses or other biosafety level 4 viruses
- detection or quantification of markers of parasite infection
- detection of blood grouping markers.
The deadlines for this wave are:
- for laboratories to submit applications to their Member State – 15 January 2026 (indicative, please check with your Member State)
- for the Member States to forward applications to the Commission – 15 April 2026.
Laboratories interested in applying are invited to contact the competent authority of the Member State where they are established using the national contact points list below.
Call for applications 2022
In July 2022, the Commission, after consulting the Member States in the Medical Device Coordination Group, launched a call to Member States to submit applications on behalf of their candidate laboratories for designation of EURLs.
Following this call, 5 EURLs were designated in four categories of class D devices by Commission Implementing Regulation (EU) 2023/2713.
Conformity assessment in the absence of EURLs
Regarding the conformity assessment of devices without a designated EURL, they may still be certified by notified bodies and placed on the EU market according to Regulation (EU) 2017/746.
The EURL-related elements of the conformity assessment do not apply to them until an EURL is designated. Please see MDCG 2021-4 for guidance on how EURLs should be integrated into the conformity assessment process when designated.