Designation of EU reference laboratories for high-risk in vitro diagnostic medical devices
date: 06/12/2023
On 5 December 2023, the European Commission adopted an implementing act designating 5 EU reference laboratories (EURLs) in the field of in vitro diagnostic medical devices (IVDs). These EURLs will be involved in conformity assessment of high-risk (class D) IVDs as well as carry out certain advisory tasks. The designated EURLs together cover the following categories of class D IVDs:
- Hepatitis and retroviruses
- Herpesviruses
- Bacterial agents
- Respiratory viruses that cause life-threatening diseases
The implementing act includes transitional arrangements to allow the EURLs to form a network and harmonise their working methods, and for manufacturers and notified bodies to adapt their processes to include EURL testing. The EURLs are expected to take up their tasks in conformity assessment of devices on 1 October 2024.
The act includes provisions to minimise disruption to ongoing conformity assessment processes. In particular, only new applications submitted to notified bodies after the end of the transition period will be subject to performance verification by the EURLs. On the other hand, batch testing of devices already CE-marked under Regulation (EU) 2017/746 will begin after the end of the transitional period to ensure appropriate control of those IVDs.