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European Medtech SMEs Are In Denial Over EU MDR And New Clinical Data Needs

Executive Summary

The EU Medical Device Regulation (MDR) is front and center for global medtech companies wanting to succeed in the EU in the next decade and beyond. Or at least it should be, but the fear is that smaller players are not ready for its stringent clinical trials regulations and many other key changes it will bring. The potential impact on the medtech ecosystem and the flow of innovation in Europe is becoming a serious concern.

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