App Store Introduces Transparency Rules for Medical Device Apps Across EEA, UK and US
Apple has introduced a new update to the App Store that will display whether an app qualifies as a regulated medical device in the European Economic Area, United Kingdom and United States.
Regulated medical device apps include those used for diagnosis, monitoring, prevention or treatment of medical conditions. These apps may require approval or registration from authorities such as the U.S. Food and Drug Administration.
Developers distributing apps in these regions must now declare their app’s regulatory status in App Store Connect if the app falls under Health and Fitness or Medical categories, or includes medical-related content. They are also required to provide supporting regulatory details such as safety information and contact data.
The requirement is effective immediately for new apps. Existing apps must comply by early 2027. Apps that do not declare their status by the deadline will not be allowed to submit updates.
The update is aimed at improving transparency and helping users better understand the nature and regulatory status of health-related apps.
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