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Apple is updating App Store requirements for health and medical apps distributed in the EEA, UK, and US. Starting now, new apps in the Health & Fitness or Medical categories — or those flagged for medical content in the Age Rating questionnaire — must declare their regulated medical device status in App Store Connect. Existing apps have until early 2027 to comply, after which failure to declare status will block app updates. The App Store will display this status on product pages to improve transparency for users.

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