Commission Implementing Regulation (EU) 2025/2526 of 16 December 2025 amending Implementing Regulation (EU) 2023/2713 to correct the designation of an EU reference laboratory and to designate European Union reference laboratories for in vitro diagnostic medical devices intended for detection or quantification of markers of parasite infection and detection of blood grouping markers

• CELEX: Implementing Regulation (EU) 2025/2526
• Articles: 3

Article 1

The Annex to Implementing Regulation (EU) 2023/2713 is amended in accordance with the Annex to this Regulation.

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, point 3 of the Annex to this Regulation shall apply from 1 May 2026.

3.   Without prejudice to paragraph 2 of this Article, the EU reference laboratories designated in point 3 of the Annex to this Regulation 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 May 2026.

Schedules & Appendices

ANNEX

ANNEX

The Annex to Implementing Regulation (EU) 2023/2713 is amended as follows:

(1)

point 2(a) is replaced by the following:

‘(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°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;’;

(2)

point 3(a) is replaced by the following:

‘(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°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;’;

(3)

the following points 5 and 6 are added:

‘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;

(c)

RISE Research Institutes of Sweden AB, Brinellgatan 4, 504 62, Borås, Sweden.’.