On 5 December 2023, the EU Commission adopted implementing act Regulation (EU) 2023/2713, designating five EU Reference Laboratories.

The announcement and background, is available: HERE

Background

EU Reference Laboratories (EURLs) are a new concept introduced under the IVDR. Among other things, EURLs are involved in the conformity assessment process for Class D IVDs, validating performance claims made by the manufacturer.

Scope

Regulation (EU) 2023/2713 designates 5 EURLs. They cover the following categories of Class D IVDs:

• Hepatitis and retroviruses
• Herpesviruses
• Bacterial agents
• Respiratory viruses that cause life-threatening diseases

Transition Period

Prior to this, there were no EURLs available. In the absence of any designated EURLs, MDCG 2022-3 advised “where an EURL is not yet available for the device, then the EURL related requirements are not applicable to the device”.

Regulation (EU) 2023/2713 grants a transitional period and will apply from 1 October 2024. This is so the EURLs can “form a network and harmonise their working methods” and for “manufacturers and notified bodies to adapt their processes to include EURL testing”.

Further, it ensures that there is minimal disruption:

• EURL requirements will apply only for applications newly submitted after the transition period ends. It will not be required for devices already in the conformity assessment process before the transition period ends.
• Batch testing of devices that already achieved IVDR CE marking will commence after the transition period has ended.

List of the New EURLs

Hepatitis and retroviruses

• EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51–59, 63225, Langen, Germany;
• Instituto de Salud Carlos III, Carretera de Majadahonda – Pozuelo, Km. 2,200, 28220, Majadahonda, Madrid, Spain

Herpesviruses

• Consortium managed by: Servicio Madrileño de Salud (SERMAS), Paseo de la Castellana 280, 28046, Madrid, Spain, and 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
• Instituto de Salud Carlos III, Carretera de Majadahonda – Pozuelo, Km. 2,200, 28220, Majadahonda, Madrid, Spain
• Consulting Químico Sanitario SLU, Calle Marie Curie 7, 28521, Rivas-Vaciamadrid, Madrid, Spain

Bacterial agents

• 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
• Instituto de Salud Carlos III, Carretera de Majadahonda – Pozuelo, Km. 2,200, 28220, Majadahonda, Madrid, Spain
• Consulting Químico Sanitario SLU, Calle Marie Curie 7, 28521, Rivas-Vaciamadrid, Madrid, Spain

Respiratory viruses that cause life-threatening diseases

• 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