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

Type Implementing Regulation

Publication 2023-12-06

Last updated 2026-05-01

State In force

Department European Commission, SANTE

Source EUR-Lex

articles 2

Reform history JSON API

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 enter into force on the third day following that of its publication in the Official Journal of the European Union.

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.

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.

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

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 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;

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;

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.

5.EU reference laboratories for devices intended for detection or quantification of markers of parasite infection:

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

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

6.EU reference laboratories for devices intended for detection of blood grouping markers:

(a) EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51–59, 63225, Langen, Germany;

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

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