The European Commission may designate EU reference laboratories (EURLs) for high-risk in vitro diagnostic medical devices (IVDs) according to Article 100 of Regulation (EU) 2017/746.
The EURLs have two main categories of tasks: advisory ones and those related to conformity assessment, particularly of the highest risk, i.e., class D devices.
For conformity assessment of class D devices, the EURLs will:
- verify the performance of class D devices and compliance with common specifications,
- perform batch testing of class D devices.
The European Commission may launch calls to Member States to submit applications for candidate EURLs. Following the assessment of compliance with criteria, the Commission can designate EURLs by implementing act.
The following implementing acts are relevant for EURLs in the field of IVDs:
- Commission Implementing Regulation (EU) 2022/944 on tasks and criteria for the EURLs
- Commission Implementing Regulation (EU) 2022/945 on fees that the EURLs may levy from notified bodies and Member States
EURL designation 2023
In July 2022, the European Commission launched a call for the designation of EU reference laboratories in 8 categories of class D devices. The Commission reviewed the applications based on the following elements specified in the call:
- the applicant laboratories must satisfy all the criteria
- the combined capacity of all compliant laboratories in a given category must cover the expected volume of requests for tasks related to the conformity assessment of devices.
Following the completion of the selection procedure in December 2023, the European Commission designated 5 EU reference laboratories covering the following categories of class D devices:
- Hepatitis and retroviruses
- Herpesviruses
- Bacterial agents
- Respiratory viruses that cause life-threatening diseases
The designation was done by the following implementing act:
For the remaining 4 categories, namely arboviruses, haemorrhagic fever and other biosafety level 4 viruses, parasites and blood grouping, there were either no laboratories that satisfied the criteria or their combined capacity was insufficient to cover the expected volume of requests.
Therefore, no EU reference laboratory was designated for these categories of devices following this call.
Transitional arrangements for EURL testing
The designation 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 the conformity assessment of devices on 1 October 2024.
Future calls
The Commission, after consulting the Member States in the Medical Device Coordination Group, is considering launching a second call to cover the remaining categories of class D devices:
- Arboviruses
- Haemorrhagic fever and other biosafety level 4 viruses
- Parasites
- Blood grouping
Interested laboratories are invited to informally express interest to their Member State by 30 April 2024.
Should there be significant interest, a formal call for applications could be launched in the near future.
Conformity assessment in the absence of EURLs
Regarding the conformity assessment of devices without a designated EURL, they may still be certified by notified bodies and placed on the EU market according to Regulation (EU) 2017/746.
The EURL-related elements of the conformity assessment do not apply to them until an EURL is designated. Please see MDCG 2021-4 for guidance on how the EURLs should be integrated into the conformity assessment process when designated.