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Premarket Innovators And SMEs (Part 1): How Many Will Survive EU MDR?

How delays in EU MDR compliance now threaten the lifeblood of the medtech industry

Executive Summary

The EU Medical Device Regulation threatens the viability of many premarket innovators and SMEs in the UK, and across Europe. Eithne Lee, of ISO Life Sciences global consultancy, explains how the new requirements come as a shock for many small companies, how many are ill-prepared and how the cost of compliance relative to turnover may be too high. This is part one of a two-part article.

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