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QUOTED. Aug. 2, 2018. Mark Cusworth.

Executive Summary

The EU Medical Device Regulation (MDR) introduces additional information that needs to be included on product labels, forcing device-makers to design new label templates. That's a design and data challenge that must quickly be addressed to avoid a sticky situation, Mark Cusworth, VP of R&D at label management software firm Prism ID, writes in a guest column for Medtech Insight. See what he wrote here.

"The labeling of medical devices is already complex, encountering multiple organizational touchpoints across a diverse end-to-end process. That is why labeling has become a mission-critical business system for medical device companies. However, EU MDR brings added complexity and is forcing companies to review their labeling infrastructure as they battle for organizational preparedness. It’s a battle that won’t be won overnight – but it needs to start now." –Mark Cusworth, VP of research and development, Prisym ID

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