Advanced Textiles Expo 2025

Sessions Speakers Exhibitors Floor Plan

Medical Products vs. Medical Devices (Room Indiana Convention Center, Room 139)

04 Nov 25
9:00 AM - 9:50 AM

Tracks: Emerging Technologies Conference

What’s the difference between a healthcare product and a medical device? How are they regulated and what claims can you make? Compliance with the EU Medical Device Regulation (MDR) and the U.S. FDA requirements for medical devices can be complicated – and avoiding medical claims on consumer products is just as important. We’ll discuss the requirements for both, focusing especially on biological safety and performance.