Second call to Member States to submit further applications on behalf of their candidate laboratories for designation of EURLs

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.

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:

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.

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.