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Footwear as a Medical Device in the EU

Sep 15, 2025 World Footwear Reports
Footwear as a Medical Device in the EU
Can classifying shoes as medical devices unlock new opportunities?

The World Footwear is launching a new series of innovation papers dedicated to innovation in the footwear and leather goods industry.


The latest World Footwear Innovation Paper focus on footwear as a medical device within the European Union. You can learn more about the EU's regulatory framework, the challenges and opportunities for footwear businesses by accessing this paper.



Published in September 2025


Contents
Summary
Introduction
What is a Medical Device?
Footwear as a Medical Device
Claims are Insufficient for Medical Device Classification
Obligations when Footwear is Considered a Medical Device
Brief Overview of the U.S. Regulation
Challenges and Opportunities
Key Takeaways
References