Apple will show ‘regulated medical device’ status on App Store pages in the EEA, UK, and US

Original post (source): Apple Developer News - “Update on regulated medical device apps in the European Economic Area, United Kingdom, and United States” (Mar 26, 2026)

• https://developer.apple.com/news/?id=nyqbfz1y

Summary

Apple is adding a new transparency label to some App Store product pages in the EEA, UK, and US: whether the app is a regulated medical device.

If your app distributes in any of those regions and either:

• your primary or secondary category is Health & Fitness or Medical, or
• you marked frequent references to Medical or Treatment Information in the Age Rating questionnaire,

…you now need to declare a regulated medical device status in App Store Connect, plus supporting regulatory details.

For new apps, this is required starting now to distribute in those regions. For existing apps, the deadline is early 2027. After that, Apple says you won’t be able to submit updates if you haven’t declared status.

What Apple is really doing here

This is less about marketing, and more about risk and clarity:

• Users get a cleaner signal about what they’re downloading.
• Apple gets a structured compliance workflow inside App Store Connect.
• Health teams get one more thing that can block releases if it’s missed.

If you run a health-related app, treat this like a release-critical checklist item, not an “eventually” task.

What to do next (tiny wins)

1. Inventory which apps are in scope

   • Check category assignments (primary + secondary).
   • Re-open the Age Rating questionnaire and confirm whether you’ve flagged frequent medical/treatment references.

2. Add the status decision to your ship checklist

   • “Regulated medical device?” is now a gating question for the EEA/UK/US if you’re in the affected categories.

3. If you’re not a regulated medical device, still file the ‘No’

   • This is the low-effort path that avoids last-minute release friction later.

Apple’s help doc (workflow):

• https://developer.apple.com/help/app-store-connect/manage-app-information/declare-regulated-medical-device-status