Apple’s App Store will show if an app is classified as a regulated medical device
appleinsider.com Mar 27, 2026

Apple’s App Store will show if an app is classified as a regulated medical device

AI-summarised brief · reviewed before publication

Apple's App Store will now label apps that meet select criteria for medical devices in the US, EU, and UK. Developers offering apps with medical uses or connecting to medical devices must register with the FDA in the US, and similar regulations exist in the UK and EU. To qualify, an app must be available in one of these regions and meet three criteria outlined in Apple's developer documentation.