To provide additional transparency for customers, the App Store now displays whether an app is a regulated medical device on its product page in the European Economic Area (EEA), United Kingdom or United States. Regulated medical device apps are those that function alone or as part of a system for a number of medical purposes, including diagnosis, prevention, monitoring and treatment of diseases and physiological conditions. These apps may require registration or authorization from regulatory bodies, such as the US Food and Drug Administration (FDA).
If you distribute in the EEA, UK or US and your app meets one of the following criteria, you must provide a regulated medical device status in App Store Connect, along with relevant regulatory information, such as contact details and security information:
- Its primary or secondary category is Health & Fitness or Medicine
- It has been shown that it often contains references to medical or treatment information in the Age Rating Questionnaire in App Store Connect
Starting today, this status is required for new apps that meet either of the above criteria to be distributed in these regions. Existing apps distributed in these regions that meet either of the above criteria must provide a status until the beginning of 2027. However, if you have not declared the status of your app by the beginning of 2027, you will no longer be able to submit app updates. If your app is not a regulated medical device, you can choose No.
Learn about delivery from a regulated medical provider Device status