Background - 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. Applicant laboratories had six months to prepare and submit applications to their Member State.
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 each 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 following act designates the laboratories:
For the remaining 4 categories, namely arboviruses, haemorrhagic fever and other biosafety level 4 viruses, parasites and blood grouping, at the closing time of the call there were either no applicants 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 the first call.
Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical dev
Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices
health.ec.europa.eu
