News Category: Regulatory news
The European Commission has opened its call for Member States to submit applications on behalf of candidate EU Reference Laboratories for IVDs (EURLs). EURLs will play an important role in batch testing and verifying the performance of high-risk (Class D) in vitro diagnostic medical devices (IVDs).
Laboratories in the following areas can apply:
- Hepatitis and retroviruses
- Bacterial agents
- Respiratory viruses that cause life-threatening diseases
- Haemorrhagic fever and other biosafety level 4 viruses
- Blood grouping
If your lab is interested in applying for designation, please review our EURL webpage for more details on how to apply to us.
We ask interested candidates to inform us of their intention to apply for designation as an EURL by close of business on 30 September 2022.
For more information about the tasks, criteria and fees that EURLs may levy from notified bodies and Member States, please review the Commission’s EURL webpage.
The Commission has also published an information pack for candidate laboratories. This document summarises the key considerations for EURLs operating under the In Vitro Diagnostic Medical Devices Regulation (IVDR).