Apple is tightening how it handles medical apps on the App Store in the US, the UK, and the European Economic Area. Under the updated policy, qualifying apps will need to disclose whether they are considered regulated medical devices, and that information will be shown directly on their App Store product pages.
According to details published by Apple and highlighted by MacRumors, an app can fall into this regulated category if it works on its own or as part of a broader medical system to diagnose, prevent, monitor, or treat disease. Apple also says apps flagged in the App Store age-rating questionnaire as frequently involving medical or treatment information may be required to declare their regulatory status as well.
For developers, the new rule adds a clear compliance step. Apple now expects affected app makers to submit formal regulatory information through the developer backend. Future App Store listings for these apps may display data such as a manufacturer’s Single Registration Number in Europe or an operator number issued by the FDA in the United States, along with links to usage instructions, intended-purpose statements, and safety notices.
Apple is not giving everyone the same deadline. New submissions that meet the criteria must follow the rule immediately. Existing apps already available on the store have a longer runway, but developers will need to complete the required declaration process before the start of 2027.
If they don’t, Apple says those apps could lose the ability to receive version updates. That makes this more than a labeling change. For health-focused developers selling into the US, UK, or EEA, the updated review process could directly affect whether their software stays active and maintainable on the App Store.
The move also shows Apple taking a more visible compliance posture around digital health software. Instead of leaving regulatory context buried in support documents or external websites, the company seems to want key approval and safety information presented right where users decide whether to download an app.
