Go-Ahead For Appointment Of European Union Reference Labs For IVDs
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.
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The IVD Regulation has tightened the stringency of third-party review of IVDs. But a vital structure is still missing. This is the latest advice for notified bodies on what to do for now.
The highest risk IVDs are due to receive an extra layer of regulatory scrutiny in the EU. But it is taking a long time to set up the structures needed.
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.