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Medtechs Must Act Fast On New EU Regulations Or Face Gridlock

Executive Summary

Following the recent vote in the European Parliament, the EU has finally adopted the Medical Device and IVD Regulations that were proposed back in September 2012. The texts, vastly longer and more complex than the three directives they are replacing, will establish a tougher regulatory code for the next decade or more, but where are the likely pressure points for industry and how can manufacturers prepare?

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