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Apple App Store now requires apps in the Health & Fitness or Medical categories to declare their regulated medical device status for distribution in the EEA, UK, and US.
•Starting March 26, 2026, new apps meeting the criteria must provide a regulated medical device status before they can distribute in these regions.
•Existing apps have until early 2027 to declare their status, or they will lose the ability to submit updates.
•Apps qualify if their primary/secondary category is Health & Fitness or Medical, or if they reference Medical or Treatment Information in the Age Rating questionnaire.
•Developers must submit relevant regulatory information including contact details and safety information via App Store Connect.
•Apps that are not regulated medical devices can simply select "No" to satisfy the requirement.
This summary was automatically generated by AI based on the original article and may not be fully accurate.
Apple
Figma
Smashing Magazine