European Commission: EU Reference Laboratories Designated for IVDs
On 5 December 2023, the European Commission (EC) announced that it has adopted an implementing act to designate five EU reference laboratories (EURLs) for class D in vitro diagnostic medical devices (IVDs).
Under Article 100 of the IVD Regulation (EU) 2017/746, the EU is obliged to designate EURLs.
The designated EURLs are scheduled to become operational on 1 October 2024. Together, they cover four categories of high-risk IVDs:
- Hepatitis and retroviruses
- Herpesviruses
- Bacterial agents
- Respiratory viruses that cause life-threatening diseases
The reference laboratories perform conformity assessments and advisory tasks for high-risk IVDs and carry out both batch and performance tests.
In addition to the four categories mentioned above, there were four other areas requested by the EU for which there are currently no reference laboratories: Arboviruses, haemorrhagic fever and other biosafety level 4 viruses, parasites and blood grouping.
A list of all designated laboratories can be found in the annex to the implementing act.
Source:
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