Update on regulated medical device apps in the European Economic Area, United Kingdom, and United States

To provide additional transparency to customers, the App Store will now display 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 on their own or as part of a system for a range 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 U.S.