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

• CELEX: Implementing Regulation (EU) 2023/2713
• Articles: 3

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.

Schedules & Appendices

ANNEX EU reference laboratories designated in accordance with Article 1

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.