The first reference laboratories were designated with Implementing Regulation (EU) 2023/2713:
1. EU reference laboratories for devices intended for detection or quantification of markers of hepatitis or retrovirus infection:
a) EU-Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51-59, 63225 Langen, Deutschland
b) Instituto de Salud Carlos III, Carretera de Majadahonda — Pozuelo, Km. 2.200, 28220 Majadahonda (Madrid), Spanien
2. EU reference laboratories for devices intended for detection or quantification of markers of herpesvirus infection:
a) Konsortium unter der Leitung des Servicio Madrileño de Salud (SERMAS), Paseo de la Castellana 280, 28046 Madrid, Spanien mit folgenden Mitgliedern:
Hospital General Universitario Gregorio Marañón, C/Doctor Esquerdo 46, 28007 Madrid, Spanien
Hospital Universitario la Paz, Paseo de la Castellana 261, 28046 Madrid, Spanien
Hospital Universitario Ramón y Cajal, Carretera de Colmenar Viejo Km. 9,100, 28034 Madrid, Spanien
b) Instituto de Salud Carlos III, Carretera de Majadahonda — Pozuelo, Km. 2.200, 28220 Majadahonda (Madrid), Spanien
c) Consulting Químico Sanitario SLU, Calle Marie Curie 7, 28521 Rivas-Vaciamadrid (Madrid), Spanien
3. EU reference laboratories for devices intended for detection or quantification of markers of infection with bacterial agents:
a) Konsortium unter der Leitung des Servicio Madrileño de Salud (SERMAS), Paseo de la Castellana 280, 28046 Madrid, Spanien mit folgenden Mitgliedern:
Hospital General Universitario Gregorio Marañón, C/Doctor Esquerdo 46, 28007 Madrid, Spanien
Hospital Universitario la Paz, Paseo de la Castellana 261, 28046 Madrid, Spanien
Hospital Universitario Ramón y Cajal, Carretera de Colmenar Viejo Km. 9,100, 28034 Madrid, Spanien
b) Instituto de Salud Carlos III, Carretera de Majadahonda — Pozuelo, Km. 2.200, 28220 Majadahonda (Madrid), Spanien
c) Consulting Químico Sanitario SLU, Calle Marie Curie 7, 28521 Rivas-Vaciamadrid (Madrid), Spanien
4. EU reference laboratories for devices intended for detection or quantification of markers of respiratory virus infection:
a) EU-Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51-59, 63225 Langen, Deutschland
b) RISE Research Institutes of Sweden AB, Brinellgatan 4, 504 62 Borås, Schweden
Conclusion:
For many class D products (including in the field of blood grouping serology) there are still no EU reference laboratories available and the EU Commission leaves it up to the notified bodies to establish reliable procedures for the verification of manufactured products.