DECEMBRIE 2025 – The European Commission published COMMISSION IMPLEMENTING REGULATION (EU) 2025/2526 OF 16 DECEMBER 2025 amending Implementing Regulation (EU) 2023/2713 to correct the designation of an EU reference laboratory and to designate European Union reference laboratories for in vitro diagnostic medical devices intended for detection or quantification of markers of parasite infection and detection of blood grouping markers – https://eur-lex.europa.eu/legal-content/RO/TXT/PDF/?uri=OJ:L_202502526
MARCH 2025 – Launch of the call for the designation of EU reference laboratories 2024-2026
In February 2025, the European Commission, after consulting Member States within the Medical Device Coordination Group (MDCG), launched a second call for Member States to submit new applications on behalf of their candidate laboratories for the designation of European Union Reference Laboratories.
There will be two steps:
1. The first step is intended for applications for the following categories of class D in vitro diagnostic medical devices:
• Detection or quantification of markers of the arbovirus infection
• Detection or quantification of markers of the parasite infection
• Detection of blood group markers.
Deadlines for this step:
– for candidate laboratories to submit the application to the Member State – 15 April 2025
– for Member States to send the applications to the European Commission – 6 June 2025.
2. The first step is intended for applications for the following 8 categories of class D in vitro diagnostic medical 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 the infection with bacterial agents
• Detection or quantification of markers of the arbovirus infection
• Detection or quantification of markers of the respiratory virus infection
• Detection or quantification of markers of the infection with hemorrhagic fever viruses or other biosafety level 4 viruses
• Detection or quantification of markers of the parasite infection
• Detection of blood grouping markers
Deadlines for this step:
– for candidate laboratories to submit the application to the Member State – 15 January 2026
– for Member States to send the applications to the European Commission – 15 April 2026.
The European Commission has updated the Information pack for candidate laboratories, Version 5 – March 2025 – https://health.ec.europa.eu/document/download/86752fcd-bc89-4eb0-8f33-643429011db6_en?filename=md_candidate-laboratories_infopack_en.pdf
Interested laboratories are invited to express their interest by contacting the NAMMDR at the e-mail address drsp@anm.ro by 15 April 2025.
LATEST NEWS ON DESIGNATION OF EU REFERENCE LABORATORIES
The European Commission, after consulting the Member States within the Medical Device Coordination Group, considers launching a second call to cover the remaining categories of class D in vitro diagnostic medical devices:
– Detection or quantification of markers of the arbovirus infection
– Detection or quantification of markers of the infection with hemorrhagic fever viruses or other biosafety level 4 viruses
– Detection or quantification of markers of the parasite infection
– Detection of blood grouping markers
Interested laboratories are invited to express their interest by contacting the NAMMDR at the e-mail address drsp@anm.ro by 30 April 2024.
For more information, please access the following link:
DESIGNATION OF EU REFERENCE LABORATORIES
In July 2022, the European Commission launched a call for designation of European Union reference laboratories for 8 categories of class D in vitro diagnostic medical devices.
The selection took place in two steps. First, Member States verified and documented whether candidate laboratories in their country complied with the selection criteria. Afterwards, Member States submitted 8 applications for further consideration by the European Commission.
The Commission analyzed the applications received based on the following elements specified in the appeal:
– the requesting laboratories must comply with all selection 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 completion of the selection procedure in December 2023, the European Commission has designated 5 EU reference laboratories covering the following categories of class D in vitro diagnostic medical devices:
1. Hepatitis and retroviruses
2. Herpesviruses
3. Bacterial agents
4. Respiratory viruses that cause life-threatening diseases
The designation was made by the following implementing act – COMMISSION IMPLEMENTING REGULATION (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices.
The regulation can be downloaded by accessing the following link:
https://eur-lex.europa.eu/legal-content/RO/TXT/PDF/?uri=OJ:L_202302713
For the remaining 4 initially proposed categories, namely:
1. Detection or quantification of markers of the arbovirus infection
2. Detection or quantification of markers of the infection with hemorrhagic fever viruses or other biosafety level 4 viruses
3. Detection or quantification of markers of the parasite infection
4. Detection of blood grouping markers
there were either no candidate laboratories which met 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.
The designation act includes transitional arrangements to allow EURLs to form a network and harmonize their working methods, and for manufacturers and notified bodies to adapt their processes to include testing through EURLs.
Additional calls for designation of EU reference laboratories in the field of IVDs may be launched in the future and related information will be published on the European Commission page available at:
https://health.ec.europa.eu/medical-devices-vitro-diagnostics/eu-reference-laboratories-eurls_en