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How far will medtech go to avoid mandatory standards?

This article was originally published in Clinica

Executive Summary

Should some European medical device standards be made mandatory? I can see many readers reel in horror. Yet, this is one of the possible answers to the question: What is the EU medical devices industry willing to accept in terms of tougher requirements to avoid the system of IVD-type Common Technical Specifications, or the involvement of European Medicines Agency (EMEA) for some medical devices? These options are now under consideration at the European Commission.

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