Fivefold Increase In MDR Notified Body Demand Could Lead EU Into Chaos
Latest EU survey predicts unprecedented hike in demand for notified body assessments between 2021 and 2024 and insufficient notified body capacity under the Medical Device Regulation.
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Waiting until the grace period expires before making a product application under the EU MDR or IVDR is a gambit that could easily misfire, TEAM-NB warns.
The latest update in the Medical Device Regulation page of the European Commission's Nando database represents the 18th listing under the new regulation. Numbers are rising slowly.
Growing evidence demonstrates the one-year delay to the Medical Device Regulation, plus the expansion of the scope of products that could remain on the market beyond the MDR date of application, have simply pushed problems to 2024.