Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices

Article 1

The laboratories listed in the Annex are designated as EU reference laboratories for the specific devices or a category or group of devices, or for specific hazards related to a category or group of devices, as specified in that Annex.

Article 2

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX

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, Germany;

(b) Instituto de Salud Carlos III, Carretera de Majadahonda – Pozuelo, Km. 2,200, 28220, Majadahonda, Madrid, Spain.

2.EU reference laboratories for devices intended for detection or quantification of markers of herpesvirus infection:

(a) Consortium managed by: Servicio Madrileño de Salud (SERMAS), Paseo de la Castellana 280, 28046, Madrid, Spain and composed of Hospital General Universitario Gregorio Marañón and Fundación para la Investigación Biomédica del Hospital Gregorio Marañón, C/Doctor Esquerdo n^o46, 28007, Madrid, Spain, Hospital Universitario la Paz, Paseo de la Castellana 261, 28046, Madrid, Spain, and Hospital Universitario Ramón y Cajal, Carretera de Colmenar Viejo Km 9,100, 28034, Madrid, Spain;

(b) Instituto de Salud Carlos III, Carretera de Majadahonda – Pozuelo, Km. 2,200, 28220, Majadahonda, Madrid, Spain;

(c) Consulting Químico Sanitario SLU, Calle Marie Curie 7, 28521, Rivas-Vaciamadrid, Madrid, Spain.

3.EU reference laboratories for devices intended for detection or quantification of markers of infection with bacterial agents:

(a) Consortium managed by: Servicio Madrileño de Salud (SERMAS), Paseo de la Castellana 280, 28046, Madrid, Spain and composed of Hospital General Universitario Gregorio Marañón and Fundación para la Investigación Biomédica del Hospital Gregorio Marañón, C/Doctor Esquerdo n^o46, 28007, Madrid, Spain, Hospital Universitario la Paz, Paseo de la Castellana 261, 28046, Madrid, Spain, and Hospital Universitario Ramón y Cajal, Carretera de Colmenar Viejo Km 9,100, 28034, Madrid, Spain;

(b) Instituto de Salud Carlos III, Carretera de Majadahonda – Pozuelo, Km. 2,200, 28220, Majadahonda, Madrid, Spain;

(c) Consulting Químico Sanitario SLU, Calle Marie Curie 7, 28521, Rivas-Vaciamadrid, Madrid, Spain.

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, Germany;

(b) RISE Research Institutes of Sweden AB, Brinellgatan 4, 504 62, Borås, Sweden.