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.