Expression of Interest for EU reference laboratories

The European Commission launched a second call for EU reference laboratories (EURLs) for high-risk in vitro diagnostic medical devices to cover the 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

Laboratories established in Malta wishing to express their interest to be designated as EURLs for the aforementioned categories are kindly invited to contact the Malta Medicines Authority on devices.medicinesauthority@gov.mt by 30 December 2025

Further details are available through the following link: https://health.ec.europa.eu/medical-devices-vitro-diagnostics/eu-reference-laboratories-eurls_encall-for-applications-2025-2026