According to IVDR 2017/746, EU reference laboratories shall “verify the performance claimed by the manufacturer and the compliance of class D devices with the applicable CS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent, as provided for in the third subparagraph of Article 48(3);”. In other words, for Class D devices, the performance claimed by the manufacturer and compliance of CS (common specification) where applicable, should be verified by the EU reference laboratories with appropriate tests and for Class C devices when requested by Member of States according to Article 100 (2) and (3) respectively.
As Stated in the European Commission “COMMISSION IMPLEMENTING REGULATION (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices” Class D devices have to undergo performance verification and batch testing by EU reference laboratory.
Designated EU reference laboratories and their scope are as below:
|
Scope (Detection or quantification of markers of..) |
Designated Laboratory |
|
Hepatitis or retrovirus infection |
EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut - Germany |
|
Instituto de Salud Carlos III - Spain |
|
|
Herpesvirus infection and Infection with bacterial agents |
Consortium managed by: Servicio Madrileño de Salud (SERMAS) - Spain composed of: Hospital General Universitario Gregorio Hospital Universitario la Paz, Paseo de la Castellana Hospital Universitario Ramón y Cajal, Carretera de Colmenar Viejo Km 9,100, 28034, Madrid, Spain; |
|
Instituto de Salud Carlos III - Spain |
|
|
Consulting Químico Sanitario SLU - Spain |
|
|
Respiratory virus infection |
EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut - Germany |
|
RISE Research Institutes of Sweden - Sweden |
Designated reference laboratories given above are expected to start from 1 October 2024.
References
1. COMMISSION IMPLEMENTING REGULATION (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices (Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices (europa.eu))
