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EU Medtech Regulation: Uncertainty, Delays and Brexit Create The Perfect Storm

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Introduction

Industry has reason to be concerned when it comes to the European Commission's draft Commission implementing Decision on medtech standards and the delays that now look inevitable for most standards work.

Medtech Insight's Amanda Maxwell spoke to Oliver Bisazza, director of regulations and industrial policy at Europe's largest medtech trade association, MedTech Europe, to gauge his sense of how the standards request from the European Commission, in the form of the draft Commission Implementing Decision to the European standards bodies, is shaping up.

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