European Union Reference Laboratories (EURLs)

This webpage provides laboratories with details on how to submit an application for designation as an EURL.

About EURLs

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
• Herpesviruses
• Bacterial agents
• Arboviruses
• Respiratory viruses that cause life-threatening diseases
• Haemorrhagic fever and other biosafety level 4 viruses
• Parasites
• 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.

How do I apply for designation as an EURL?

Step 1: Ensure you meet the EURL selection criteria

• To ensure your lab meets the selection criteria, please review the information provided in the Commission’s Call for applications for EURLs in the area of IVDs.
• The Commission has also published an Information pack for candidate labs. This document provides practical details about the overall selection process for EURLs.

Step 2: Notify us of your intention to apply

• If you would like to apply for designation as an EURL, please notify us by email at devices@hpra.ie
• In your email, please list the category(s) of class D devices that your laboratory intends to include in the application.

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.

• Annex I - estimated EU wide capacities for EURLs
• Annex III - knowledge and experience requirements for staff
• Annex IV - estimated capacity of candidates
• Annex V - declaration on exclusion criteria
• Annex VI B - simplified viability checks
• Annex VII - candidate declaration on independence
• Annex IX - application form single laboratories
• Annex X - application form consortia

(Note: There are number of annexes relevant to competent authorities only which are not listed.)

Step 4: Submit your application

• Submit your application with the required documents via the Common European Submission Portal (CESP).
• If you have not used CESP before, their website provides general information and frequently asked questions.
• In Ireland, the HPRA are accepting applications for EURL designation until 11:00am GMT on 05 January 2023.
• There will be no extension to the deadline.
• Once verified by us, we will submit the application to the Commission for consideration.

Step 5: Pay the relevant fees

• We charge a fee for the verification and submission of EURL designation applications. 
• Our Guide to Fees for Human Products outlines the categories of fee we charge. The fee associated with this process is code 474. We estimate that the aggregate hourly rate will result in a fee of €2,700.
• A Fee Application Form should be completed and submitted with all applications.
• Our Payment of Fee Instructions provides additional guidance and details when paying fees by credit transfer or EFT. 

Step 6: Notify us of your CESP reference number

• Once your submission is complete, please provide us with your CESP reference number by email to devices@hpra.ie.