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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Responses to an EU level survey indicate that there is going to be a huge bottleneck in demand for EU notified body services for assessment against the Medical Device Regulation (MDR) in 2024.

The number of expiring certificates will induce a peak in the workload of notified bodies that “will be difficult to manage”, EU notified body association, TEAM-NB, says. Its figures suggest...

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