App Store product pages will now display whether an app is a regulated medical device, Apple said today. The designation will be shown in the App Store in the European Economic Area (EEA), United Kingdom, and United States.
According to Apple, regulated medical device apps may function on their own or as part of a system for medical purposes like diagnosis, prevention, monitoring, and treatment of diseases and physiological conditions.
The apps may require registration or authorization from regulatory bodies like the Food and Drug Administration.
App developers who distribute Health and Fitness or Medical apps in the EEA, UK, or U.S. will need to provide a regulated medical device status in App Store Connect, along with associated regulatory information.
Apps that are marked as containing frequent references to medical or treatment information in the Age Rating questionnaire in App Store Connect will also need to provide the regulated medical device status.
Apple says the status is required for new apps that meet either criteria as of today. Existing apps will need to provide a status by early 2027. App developers that do not declare a status by early 2027 will no longer be able to submit app updates.
App Store pages for regulated medical devices will list an EU Manufacturer SRN or FDA Operator Number, a URL with use instructions, a use statement, and safety information.
More information is available on Apple's developer website.
