Second call for EU reference laboratories for high-risk IVDs
The Commission, after consulting the Member States in the MDCG, 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 can informally express interest to their Member State by 30 April 2024.
EU Reference Laboratories according to the IVDR should be enabled to verify by laboratory testing the performance presented by the manufacturer and the compliance of devices of highest risk with the applicable CS, when such CS are available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance.
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
For the remaining 4 categories:
- 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.
Interested laboratories are invited to informally express interest to their Member State by 30 April 2024.
You can find a list of authorities in EU Member States and other eligible countries responsible for selection of EU reference laboratories and their contact details under “Contact points for candidate EU reference laboratories”.
More information: EU reference laboratories (EURLs) https://health.ec.europa.eu/medical-devices-vitro-diagnostics/eu-reference-laboratories-eurls_en