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 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.
The European Commission has launched an initiative to ensure products without a medical purpose that fall under the Medical Device Regulation are appropriately classified by risk, and subject to the same pre- and post-market requirements as comparable medical devices.