Comments Invited on European Commission Vision For IVDR EU Reference Laboratories

Two long-awaited European Commission proposals have been published which shed light on how EU reference laboratories will operate under the IVD Regulation and likely timelines.

Lab Technician

The European Commission has published two key draft implementing regulations in the context of the IVD Regulation which is due to apply on 26 May 2022. One sets out the tasks of and criteria for EU reference laboratories (EURLs) under the regulation, and the other lays down rules regarding fees the EURLs may charge.

EURLs are a new type of scientific body. Once designated, their main role is to carry out additional tests on the highest risk, class D, IVDs.

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