The European Commission has the power to designate one or more European Union reference laboratories – EURLs for devices or for a specific category or group of devices, or for specific risks relating to a category or group of devices.
The laboratories that can be designated must meet the criteria indicated in paragraph 4 of Article 100 of Regulation (EU) 2017/746.
The European Commission may designate, by means of implementing acts, only laboratories for which a Member State has submitted an application for designation.
After the designation of first 5 laboratories occurred in December 2023 for the categories of class D devices Hepatitis and retroviruses, Herpesviruses, Bacterial agents and Respiratory viruses causing potentially lethal diseases, the Commission, in agreement with the Member States, is evaluating the possibility of evaluating new applications for the 4 categories of class D devices for which reference laboratories have not yet been designated.
The 4 categories I am:
Arbovirus hemorrhagic fever and other biosafety level 4 (BSL-4) parasite blood group viruses.
Presentation of expressions of interest
To this end, the European Commission has invited Member States to collect expressions of interest from laboratories present on their territory.
Interested laboratories based in the national territory therefore have the opportunity to present their expression of interest to the Ministry of Health by April 30, 2024.
For further information, consult the page: