Footwear as a Medical Device in the EU: Can classifying shoes as medical devices unlock new opportunities?

The classification of footwear as medical devices is gaining relevance within the European Union, particularly under the scope of Regulation (EU) 2017/745 (MDR). This framework establishes the conditions under which products such as orthopaedic, diabetic and post-surgical shoes qualify as medical devices. Certification requirements include CE marking, clinical evaluation and post-market surveillance obligations, ensuring high standards of safety and performance. The regulation also clearly delineates the responsibilities of manufacturers, thereby reinforcing consumer protection.

Demographic and health trends are central to the growing demand for medical footwear. The global rise in chronic conditions such as diabetes, combined with ageing populations and increased awareness of preventive care, is fuelling steady market growth. The footwear segment is expected to benefit particularly from these trends, with medical-grade products positioned to address mobility issues, foot deformities and recovery needs.

For footwear manufacturers, opting for medical classification may be a strategic decision that can unlock new business opportunities. Although compliance entails investment in documentation, testing and quality systems, it opens the door to public reimbursement schemes, healthcare procurement channels and niche consumer segments. Companies that successfully align their products with health-related needs and regulatory standards will be better positioned to thrive in a market shaped by demographic shifts and evolving healthcare expectations.

This document outlines the challenges and opportunities for footwear businesses as they move towards medical device classification within the European Union.

If you are not registered yet, you can log in with a social network or create an account

It is easy, free and quick – and it will allow you to unlock all our Premium content

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