Updated: New MDR Notified Body Designations Pending, But Only One Under IVDR Until Mid-Late 2022
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.
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With major concerns persisting over notified body capacity under both the EU medical device and IVD regulations, every new designation is important. The numbers continue to nudge up slowly.
The latest designation of a notified body in the context of the MDR means that the EU only needs one more to make the landmark total of 30. It seems that this may be realized soon.
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.