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Apple Requires App Developers to Declare Regulated Medical Device Status in EEA, UK, and U.S.

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App Store product pages will now display whether an app is a regulated medical device, Apple said today. The designation will be shown in the ‌App Store‌ in the European Economic Area (EEA), United Kingdom, and United States.

apple medical device status
According to Apple, regulated medical device apps may function on their own or as part of a system for medical purposes like diagnosis, prevention, monitoring, and treatment of diseases and physiological conditions.

The apps may require registration or authorization from regulatory bodies like the Food and Drug Administration.

App developers who distribute Health and Fitness or Medical apps in the EEA, UK, or U.S. will need to provide a regulated medical device status in ‌App Store‌ Connect, along with associated regulatory information.

Apps that are marked as containing frequent references to medical or treatment information in the Age Rating questionnaire in ‌App Store‌ Connect will also need to provide the regulated medical device status.

Apple says the status is required for new apps that meet either criteria as of today. Existing apps will need to provide a status by early 2027. App developers that do not declare a status by early 2027 will no longer be able to submit app updates.

‌App Store‌ pages for regulated medical devices will list an EU Manufacturer SRN or FDA Operator Number, a URL with use instructions, a use statement, and safety information.

More information is available on Apple's developer website.

Tag: United Kingdom

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Top Rated Comments

Superhai Avatar
Superhai
17 weeks ago

What about fitness apps like eg work outdoors or such? I would hope not
what about the Apple Health and Workout app?
Only apps who themselves declare as a "medical device": "Regulated medical device apps are used for a range of medical purposes, including diagnosis, prevention, monitoring, and treatment of diseases and physiological conditions." Simple workout apps will mostly don't belong here, but if it accesses health data or claim any medical purpose it will do.
Score: 3 Votes (Like | Disagree)
D
doggkruse
17 weeks ago
This is not really new, I've released regulated medical apps through apple and they've long required proof of regulatory clearance / approval. What's new here is they've created a formal designation. The previous method largely was just uploading the supporting documentation as a comment during app review
Score: 2 Votes (Like | Disagree)
Superhai Avatar
Superhai
17 weeks ago

However, I do wonder if there will be additional/future hurdles for apps which are not regulated but have some features in common with regulated medical apps?
It is now based on self-declaration by the developer, but this is also regulation in each relevant jurisdiction. Basically if you tick the right boxes you have to provide it, otherwise not. As I read into it, if you as a developer is in the borderzone but say it is not, Apple will not do anything, but the risk will be that you have misinterpreted the legislation and could face hurdles in that regard. I would probably asked for advice if I had an app on any of the app stores close to any of the categories listed by Apple.
Score: 1 Votes (Like | Disagree)
P
polyphenol
17 weeks ago
For genuine regulated medical device apps, this seems entirely appropriate. Indeed, were I a producer of such apps, I think I would have included this information in the description. Why ever not?

However, I do wonder if there will be additional/future hurdles for apps which are not regulated but have some features in common with regulated medical apps?
Score: 1 Votes (Like | Disagree)
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