EURLs have been a critical missing element of the IVDR for assessing the higher-risk class D IVDs. Two new implementing regulations, on fees and tasks, bring them closer to designation.
Two new implementing regulations have been published in the context of the EU’s IVD Regulation. The first relates to European Union reference laboratories (EURLs’) tasks, as well as criteria for their operation, and the second to their method of charging fees to manufacturers for their services.
EURLs are independent scientific and testing bodies designated by the European Commission whose role under the IVDR includes:
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