One More IVDR Notified Body In The Wings As Designation Progress Continues To Advance

Every designation of a notified body under the Medical Device and IVD Regulations has been greeted with fanfare given the historic pressure for more testing capacity. There may have been a shift in timelines, but IVD manufacturers still urgently need to engage with a certified testing body.

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One More IVD Regulation Notified Body Imminent

There are now 39 notified bodies under the Medical Devices Regulation and still 10 under the IVD Regulation. But one organization seeking designation in the context of the IVDR is already at the stage of being recommended by the Medical Device Coordination Group and so should be designated imminently. 

That is according to the latest quarterly update from the European Commission.

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