Another Italian Notified Body Is Designated Under The MDR
There are now 21 notified bodies under the Medical Device Regulation, and more are promised. Does this mean there will be sufficient testing capacity to meet the predicted 2023/2024 demand?
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MHRA Must Seize UK Digital And Diagnostics Opportunity: ABHI Perspectives On Enabling Regulation – Part 2
IVD and healthtech industry representatives give their views on how the future UK medtech system can be shaped to be agile and responsive to patients’ needs, mindful that the regulator must deliver a standalone regulatory system and functional UKCA marking in less than two years.
After the shake-up of notified bodies based in the UK in the wake of Brexit, GMED is one EU notified body that is hoping for its UK subsidiary to be designated as a UK approved body − within the next six to nine months.
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.