First EU Reference Laboratories designated under the IVDR!

The European Union designated on 5 December 2023 its first EU reference laboratories (EURL) for vitro diagnostic devices. In July 2022, the European Commission opened its call to Member States to submit applications for EU reference laboratories. 

In total, five EURLs have been designated for different purposes:

• For devices intended for the detection or quantification of markers of hepatitis or retrovirus infection the following EURLS have been designated: 
  • EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51–59, 63225, Langen, Germany
  • Instituto de Salud Carlos III, Carretera de Majadahonda – Pozuelo, Km. 2,200, 28220, Majadahonda, Madrid, Spain

• For devices intended for the detection or quantification of markers of herpesvirus infection and devices intended for the detection or quantification of markers of the infection with bacterial agents the following EURLS have been designated:
  • Consortium managed by: Servicio Madrileño de Salud (SERMAS), Paseo de la Castellana 280, 28046, Madrid, Spain
  • Instituto de Salud Carlos III, Carretera de Majadahonda – Pozuelo, Km. 2,200, 28220, Majadahonda, Madrid, Spain
  • Consulting Químico Sanitario SLU, Calle Marie Curie 7, 28521, Rivas-Vaciamadrid, Madrid, Spain

• For devices intended for the detection or quantification of markers of respiratory virus infection the following EURLS have been designated:
  • EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51–59, 63225, Langen, Germany
  • RISE Research Institutes of Sweden AB, Brinellgatan 4, 504 62, Borås, Sweden

The implementing act includes transitional arrangements to allow the EURLs to form a network and harmonise their working methods, and for manufacturers and notified bodies to adapt their processes to include EURL testing. The EURLs are expected to take up their tasks in conformity assessment of devices on 1 October 2024.

The act includes provisions to minimise disruption to ongoing conformity assessment processes. In particular, only new applications submitted to notified bodies after the end of the transition period will be subject to performance verification by the EURLs. 

The official note has been published on 6 December 2023 in the Official Journal of the EU.