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853 Apple Requires App Developers to Declare Regulated Medical Device Status in EEA, UK, and U.S.

MacRumors
Juli Clover @ MacRumors · 03/26/2026 18:41 EDT

Apple Requires App Developers to Declare Regulated Medical Device Status in EEA, UK, and U.S.

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 regula

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