The first set of EU reference laboratories (EURLs) have been named in Commission Implementing Regulation (EU) 2023/2713. EURLs are essential in the assessment of high-risk IVD medical devices (IVDs).
As a reminder, EURLs have two main types of functions: advisory as well as related to conformity assessment, chiefly of class D IVDs. As regards conformity of class D devices, the EURLs are responsible for:
- Validating the performance of these products and conformity with common specifications
- Performing batch testing of class D devices.
The designated EURLs will become active on 1 October 2024. This time will also allow manufacturers and notified bodies to modify their processes.
It is important to note that EURL involvement in class D IVDs will only be required for products where applications are made to a notified body after the aforementioned date. IVDs that have been certified before 1 October 2024 and where applications have already been accepted do not need to involve a EURL for validating the performance of these products and compliance with common specifications. Up to now, notified bodies have assessed these products. Importantly, batch verification testing will apply from 1 October 2024 for all class D devices, irrespective of whether they are already certified or in the process of certification.
The Implementing Regulation contains an annex listing reference laboratories according to ‘specific devices, or category or group of devices, or for specific hazards related to a category or group of devices’ for which they are authorised to test.
There are ten listings to date under the following four categories:
- Devices meant for detection or quantification of markers of hepatitis or retrovirus infection.
- Devices aimed at detection or quantification of markers of herpes virus infection.
- Devices intended for detection and quantification of markers of infection with bacterial agents.
- Devices planned for detection or quantification of markers of respiratory virus infection.
Source: Medtech Insight (an Informa product)