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 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