EU Regulatory Roundup, October 2023: Notified Bodies Fire On All Cylinders To Manage Challenges

Are too few manufacturers making their applications to notified bodies right now or are they applying but being turned away? Tensions are rising as notified bodies try to manage their workload and industry feels increasingly under stress.

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October saw evidence of the struggles that notified bodies are experiencing in managing their workloads. They are calling for manufacturers to apply to notified bodies now so that they can audit products in a timely and manageable way.

But manufacturers, and especially SMEs, who have suffered the impact of a challenging and piecemeal implementation of the Medical Device...

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