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

1.   This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union . 2.   For the purpose of the tasks referred to in Article 100(2) of Regulation (EU) 2017/746, this Regulation shall apply from 1 October 2024. 3.   Without prejudice to paragraph 2 of this Article, EU reference laboratories shall carry out the task referred to in Article 100(2), point (a), of Regulation (EU) 2017/746, only for devices for which manufacturers or authorised representatives lodge formal applications for conformity assessment with a notified body in accordance with Section 4.3, first subparagraph, of Annex VII to Regulation (EU) 2017/746 from 1 October 2024.

EU reference laboratories designated in accordance with Article 1

ANNEXSupplementary provisions

ANNEX EU reference laboratories designated in accordance with Article 1 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, C/Doctor Esquerdo n°46, 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, C/Doctor Esquerdo n°46, 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.