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35 Notified Bodies In The Pipeline – But Heading For Catastrophe With Tight Timing?

Executive Summary

New survey results suggest there could be a drop of about 40% in the number of EU notified bodies testing medical devices. A rough calculation points to an even bigger potential drop in the number that will be ready in time, when the Medical Device Regulation fully applies in 2020. A close look at newly available data signals the prospect for a serious bottleneck.

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