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, i.e., 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
EURL designation 2023
In July 2022, the European Commission launched a call for the designation of EU reference laboratories in 8 categories of class D devices. The Commission reviewed the applications based on the following elements specified in the call:
- the applicant laboratories must satisfy all the criteria
- the combined capacity of all compliant laboratories in a given category must cover the expected volume of requests for tasks related to the conformity assessment of devices.
Following the completion of the selection procedure in December 2023, the European Commission designated 5 EU reference laboratories by the following implementing act:
| 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: |
|
| Consulting Químico Sanitario SLU (CQS), Spain |
|
| EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut (PEI-IVD), Germany |
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| Instituto de Salud Carlos III (ISCIII), Spain |
|
| RISE Research Institutes of Sweden AB (RISE), Sweden |
|
The EURLs took up their tasks in the conformity assessment of devices on 1 October 2024.
For the remaining 4 categories, namely arboviruses, haemorrhagic fever and other biosafety level 4 viruses, parasites and blood grouping, 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 was designated for these categories of devices following this call.
Call for applications 2025-2026
In February 2025, the Commission, after consulting the Member States in the Medical Device Coordination Group, launched a second call to Member States to submit further applications on behalf of their candidate laboratories for designation of EURLs.
This call will be conducted in two waves:
1. First wave 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 deadlines for this wave are:
- for laboratories to submit applications to their Member State – 15 April 2025 (indicative, please check with your Member State)
- for the Member States to forward applications to the Commission – 6 June 2025
2. Second wave open to 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.
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 the EURLs should be integrated into the conformity assessment process when designated.