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Crack Open The Champagne! EU Reaches Agreement on Future Medtech Regulations

This article was originally published in Clinica

Executive Summary

Nearly eight years after preparatory work began, the EU has finally agreed on how medical devices and IVDs will be regulated for the foreseeable future. These regulations will now set the framework for medtech design, clinical study, manufacture and post-market vigilance for possibly the next 20 years.

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