EU’s 28th Notified Body Under The MDR Is Based In Slovenia
Another notified body has been designated under the Medical Device Regulation as demand is predicted to rise steeply in anticipation of the 26 May 2024 MDR deadline for all products.
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Latest figures published by the European Commission show some progress can be expected soon when it comes to notified body designations under the Medical Device Regulation, but very little under the IVD Regulation.
Latest information from the European Commission suggest that future notified bodies designated under the MDR, and even the IVDR, may not be in a position to issue certificates until March 2023.
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.