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

App Store product pages Apple will show regulated medical device designation on App Store pages, app Store product pages will display whether an app is a regulated medical device.

Geographic availability designation will be shown in the EEA, UK, and U.S., the designation will appear in the European Economic Area, United Kingdom, and United States.

Regulated medical device apps may operate standalone or as part of a medical system, regulated medical device apps can function alone or as part of a system for diagnosis, prevention, monitoring, or treatment.

Regulatory bodies these apps may require regulatory registration or authorization, such apps may require registration or authorization from regulators like the U.S. Food and Drug Administration.

App developers developers must declare regulated medical device status in App Store Connect, developers distributing Health and Fitness or Medical apps in the EEA, UK, or U.S. must provide regulated medical device status in App Store Connect.