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Will You Need A New Notified Body And Authorized Representative?

This article was originally published in Clinica

Executive Summary

The forthcoming new EU Medical Device Regulation, still under discussion, is going to introduce requirements the like of which have never been encountered before, and which may see the exit of a number of experienced and arguably much needed players from the EU medtech market. At least that is how it seems from a report recently published by the British Standards Institute (BSI)

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