European Union Reference Laboratories (EURLs)
This webpage provides laboratories with details on how to submit an application for designation as an EURL.
Under the In Vitro Diagnostic Medical Devices Regulation (IVDR), EURLs will play an important role in batch testing and verifying the performance of high risk (Class D) in vitro diagnostic medical devices (IVDs).
For more information about the tasks and criteria for EURLs, and the fees EURLs may levy from notified bodies and Member States, please review the Commission’s EURL webpage.
Call for designation of EURLs
The European Commission has opened the call for EURLs. This means that Member States can now submit applications on behalf of candidate EURLs for the following categories of class D IVDs
- Hepatitis and retroviruses
- Bacterial agents
- Respiratory viruses that cause life-threatening diseases
- Haemorrhagic fever and other biosafety level 4 viruses
- Blood grouping
The Commission’s Call for applications for EURLs in the area of IVDs outlines the application procedure for candidate EURLs as well as the preference and selection criteria.
Step 3: Prepare your application
- After notifying us of your intention to apply for EURL designation, we will contact you and guide you through the application process.
- The Commission has developed several template documents listed below. Laboratories should use these templates to help prepare their applications.
(Note: There are number of annexes relevant to competent authorities only which are not listed.)