The further Apple dives into medical technology, the more it will have to deal with regulators. Now, the App Store will label apps that meet select criteria for medical devices in the US, EU, and UK.
App Store will show if an app is a designated medical device
App Store will show if an app is a designated medical device
Developers that offer apps with medical uses or connect to medical devices have to be registered with the FDA in the US. Similar regulations exist in the UK and EU, and now there’s a way for developers to label their apps as a regulated medical device in the App Store.
According to Apple’s developer documentation, an app must meet three criteria to get the label. First, the app must be available in the EU, UK, or US and may or may not require registration or authorization from regulatory bodies.