The EU has finally designated 5 IVDR reference laboratories
Published Mar. 06, 2024
By Hopkins Medtech
On December 5, European time, the European Commission adopted Regulation (EU) 2023/2713, designating five EU reference laboratories that are cross-responsible for the following four IVD Category D categories:
1. IVDs for the qualitative or quantitative detection of markers of hepatitis or retroviral infection:
(1)EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut,Paul-Ehrlich-Straße 51-59,63225,Langen,Germany.
(2) Instituto de Salud Carlos III,Carretera de Majadahonda – Pozuelo,Km. 2,200,28220,Majadahonda,Madrid,Spain.
2. IVDs for qualitative or quantitative detection of markers of herpesvirus infection:
(1) Consortium managed by Servicio Madrileño de Salud (SERMAS), Paseo de la Castellana 280,28046, Madrid, Spain, and composed of.
①Hospital General Universitario Gregorio Marañón,C/Doctor Esquerdo n°46,28007,Madrid,Spain,and composed of.
②Hospital Universitario la Paz,Paseo de la Castellana 261,28046,Madrid,Spain,and
③Hospital Universitario Ramón y Cajal,Carretera de Colmenar Viejo Km 9,100,28034,Madrid,Spain.
(2) Instituto de Salud Carlos III,Carretera de Majadahonda – Pozuelo,Km. 2,200,28220, Majadahonda, Madrid, Spain.
(3) Consulting Químico Sanitario SLU,Calle Marie Curie 7,28521,Rivas-Vaciamadrid,Madrid,Spain
3. qualitative or quantitative IVDs for the detection of bacterial infection markers:
(1) Consortium managed by Servicio Madrileño de Salud (SERMAS), Paseo de la Castellana 280,28046, Madrid, Spain, and composed of.
①Hospital General Universitario Gregorio Marañón,C/Doctor Esquerdo n°46,28007,Madrid,Spain,and composed of.
②Hospital Universitario la Paz,Paseo de la Castellana 261,28046,Madrid,Spain,and
③Hospital Universitario Ramón y Cajal,Carretera de Colmenar Viejo Km 9,100,28034,Madrid,Spain.
(2) Instituto de Salud Carlos III,Carretera de Majadahonda – Pozuelo,Km. 2,200,28220, Majadahonda, Madrid, Spain.
(3) Consulting Químico Sanitario SLU,Calle Marie Curie 7,28521,Rivas-Vaciamadrid,Madrid,Spain
4. IVDs for qualitative or quantitative detection of markers of respiratory viral infections:
(1) EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut,Paul-Ehrlich-Straße 51-59,63225,Langen,Germany.
RISE Research Institutes of Sweden AB,Brinellgatan 4,504 62,Borås,Sweden.
