Is Your Watch a Medical Device: How the US and EU Regulate Fitness Wearables

An Apple Watch, an Oura Ring, or a Whoop band sits at the centre of a long-running regulatory question: when does a lifestyle gadget that becomes a regulated medical device? In 2025 and 2026, both the United States and the European Union sharpened their answers, and the two systems are moving in noticeably different directions […]



















