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Time Draws Nigh For Radical Rethink Of European medtech standards

This article was originally published in Clinica

Executive Summary

Some four years ago, the European Commission and an EU Member State effectively undermined the status of many of the key medtech standards. Work has been ongoing since to address its objections. But now, a new proposal is in the wings that could initiate the most significant overhaul of the medtech standards system in the history of EU medical device regulations. Notified body spokesman, Gert Bos, explained to Clinica why notified bodies are calling for a change.

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