One More EU MDR Notified Body In The Pipeline And Then A Gap
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.
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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.
The hope is now that a new EU document will be issued to address head on the scale of bottlenecks at notified bodies and of products needing to be removed from the market.
With a sense of desperation building among stakeholders over the challenges in ensuring all products are compliant with the Medical Device Regulation in time, high-level solutions are being considered. But a further MDR delay is not an option.