Guides
Guides
Plain-language explanations of the declaration questions app developers actually run into, traced back to the regulation, guidance, and platform documentation behind them.
US · UK · EU/NIIs my app a medical device?
Three regulators, three different legal starting points — and how they can give the same app different answers.
AppleApple's regulated medical device status questionWhat App Store Connect's declaration actually asks, region by region, and what to know before you answer it.
Google PlayGoogle Play's Health apps declarationWhy every published app has to complete it, how it relates to Health Content and Services, and what changes if you are a device.