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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

 
• By Amanda Maxwell

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.

Tightrope

The EU Medical Device Regulation (MDR) has a disproportionate impact on premarket innovators and SMEs, because while they need to meet the full requirements of the MDR, they have fewer resources to do so. And many are still not sufficiently aware of the urgency of meeting these requirements and what this involves, even at this very late stage, Eithne Lee, director at London-based ISO Life Sciences global consultancy, warned during a recent interview with Medtech Insight.

This is in contrast to the multinationals who are innovating and who have the in-house resources to project-plan their work...

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