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Will Industry Succeed Now In Thrusting Comprehensive Reform Medtech Regulations To Top Of EU Agenda?

 
• By Amanda Maxwell

It is no secret that there are significant problems in the implementation of the EU’s medtech regulations. But will EU regulators concede to industry’s latest lobbying efforts for fundamental change and accept this challenge as a starting point for discussions?

Loud & Clear
EU Medtech Industry's Lobbying Efforts Are Not Going Away • Source: Shutterstock

Structural issues in the EU’s medtech regulatory system make it slow, unpredictable, costly and complex, and lacking in agile pathways for innovation. They cannot be solved through the implementation of the Medical Device Regulation and the IVD Regulation alone.

For this reason, urgent and comprehensive reform is needed.

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