The European Commission has issued a second call for Member State laboratories to submit applications to become a European Union reference laboratory for in vitro diagnostic medical devices. The designation of these laboratories is provided for in Article 100 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
Belgian laboratories can apply as European Union reference laboratories (EURL) for in vitro diagnostic medical devices (IVDs).
These EURLs perform a number of important tasks, including verifying the performance of the highest risk IVDs (class D) and testing manufactured batches of class D IVDs.
The possible tasks of EURLs and the criteria that EURLs must meet are listed in Article 100, paragraphs 2 and 4 of Regulation (EU) 2017/746 and are specified in Implementing Regulation (EU) 2022/944. The tasks for which EURLs may invoice costs are specified in Implementing Regulation (EU) 2022/945.
A first call was made in 2022 and resulted in the designation of five EURLs in four categories of class D IVDs. This new call for candidate laboratories comes in two waves.
• A first wave open to applications in the following categories of class D IVDs :
- detection or quantification of arbovirus infection markers;
- detection or quantification of parasite infection markers;
- detection of blood group markers.
• A second wave open to applications in the following categories of class D IVDs:
- detection or quantification of hepatitis viruses and retroviruses infection markers;
- detection or quantification of herpes virus infection markers;
- detection or quantification of bacterial infection markers;
- detection or quantification of respiratory viruses infection markers;
- detection or quantification of arbovirus infection markers;
- detection or quantification of markers of infection by haemorrhagic fever viruses and other biosafety level 4 viruses;
- detection or quantification of parasite infection markers;
- detection of blood group markers.
All information on EURLs, the call for applications and practical details are available in English.
• Second call for applications for designation of EU reference laboratories in the field of in vitro diagnostic medical devices
• Information pack for laboratories (new version: March 2025)
• Annex I: scopes of designation and estimated minimum EU-wide capacity
• Annex III: knowledge and experience requirements of staff
• Annex IV: estimated minimum capacity of the candidate laboratory
• Annex V: declaration on honour regarding exclusion criteria
• Annex VI (a): criteria used for evaluation of economic and financial capacity
• Annex VI (b): simplified presentation viability checks
• Annex VII: declaration of independence
• Annex VIII: application form for single laboratories
• Annex IX: application form for a consortium
How to apply?
In Belgium, only the Federal Agency for Medicines and Health Products (FAMHP), which is the authority in charge of IVDs, can submit applications to the European Commission. The FAMHP must first verify these applications.
Candidate laboratories should therefore send their application to info.meddev@afmps.be with the following subject line "EURL application - wave X (X standing for first or second wave, so 1 or 2) - name of laboratory". Applications for the first wave can be submitted until 15 April 2025. Applications for the second wave can be submitted until 15 January 2026.
If you wish to apply for both waves, please submit separate applications.