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EU Notified Bodies Vigilant In Checking Technical Files - British Survey

This article was originally published in The Gray Sheet

Executive Summary

A survey of six European Union notified bodies (NBs) located in the UK (four), Germany (one) and Ireland (one) showed that "nearly 100%" inspected the technical files for CE-marked products during initial device manufacturer audits, John Worroll, section head, regulatory affairs and European business, UK Medical Devices Agency (MDA), said.

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