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Effective representation of non-European manufacturers: revision progress and way to go?

This article was originally published in Clinica

Executive Summary

Non-European medtech manufacturers need representation in the EU, a market that may otherwise confound them. But how clear are the rules on representation? Mika Reinikainen, chair of the European Association of Authorised Representatives (EAAR), applauds developments, and pins his hopes on further clarity brought about by the EU Commission's medical device and IVD Regulation proposals. But some further work is needed to avoid confusion in the area of market surveillance

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