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Competent authorities to tighten control over notified bodies

This article was originally published in Clinica

Executive Summary

The European system for appointing and controlling third-party medical device testing organisations is under review and likely to be changed within the next year or so. With notified bodies perceived as a weak link in the European regulatory system for medical devices, several regulatory authorities are pressing for change to make them more accountable. Among them is France, the main critic, which now has the presidency of the European Council.

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