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Designation of European Union reference laboratories for certain high-risk in vitro diagnostic medical devices

This blog was originally posted on 8th December, 2023. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

AUTHORED BY Denise McDermott , SENIOR REGULATORY COMPLIANCE SPECIALIST, COMPLIANCE & RISKS

Introduction

On 6th December 2023, the European Commission published Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 regarding the designation of European Union reference laboratories (EURLs) in the field of in vitro diagnostic medical devices.

Tasks and Responsibilities of EURLs

As per Article 100 of Regulation (EU) 2017/746, the EURLs are required for several important tasks. These tasks include verifying the performance of devices with the applicable common specifications, carrying out batch testing of class D devices, and providing scientific and technical assistance to the Commission, the Medical Device Coordination Group (MDCG), the Member States and notified bodies in relation to the implementation of this Regulation. Furthermore, the tasks of the EURLs involve development of testing and analysis methods for conformity assessment and market surveillance.

Importantly, the EURLS shall collaborate with notified bodies in the development of best practices for the performance of conformity assessment procedures. As per Article 100 of Regulation (EU) 2017/746, the EURLs shall also contribute to the development of common specifications and international standards. Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 details the tasks and criteria for EURLs in the field of in vitro diagnostic medical devices, and in July 2022 the European Commission launched a call for applications for EURLs.

Designation of EU Reference Laboratories

Following the selection process, Commission Implementing Regulation (EU) 2023/2713 now lists the laboratories 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, and these are outlined in the Annex;

1. EU reference laboratories for devices intended for detection or quantification of markers of hepatitis or retrovirus infection include;

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

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 include;

a. 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:

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

Transitional Provisions

Transitional provisions are presented in Commission Implementing Regulation (EU) 2023/2713 to allow time for manufacturers and notified bodies to tailor their conformity assessment processes to include EURL testing for Class D devices. Moreover, this transition period will allow EURLs the scope to establish and coordinate their processes. Therefore, the conformity assessment tasks required of the EURLs, as outlined in Article 100(2) of Regulation (EU) 2017/746, will begin on 1 October 2024.

Manufacturers or authorised representatives must have submitted a formal application for conformity assessment with a notified body from 1 October 2024 to allow for EURLs to perform the tasks referred to in Article 100(2)(a), of Regulation (EU) 2017/746.

References:

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices.