Starting today, some App Store apps must declare whether they are regulated medical devices in the US, UK, and Europe. Here are the details.
Developers have until early 2027 to comply
According to a new blog post on Apple’s Developer blog, “the App Store will now display whether an app is a regulated medical device on its product page in the European Economic Area (EEA), United Kingdom, or United States.”
This requirement applies to apps that meet either of the following criteria:
- Its primary or secondary category is Health & Fitness or Medical
- It’s marked as containing frequent references to Medical or Treatment Information in the Age Rating questionnaire in App Store Connect
In this case, developers will need to “provide a regulated medical device status in App Store Connect, along with relevant regulatory information, such as contact details and safety information.”
Apple says that while the new measure starts today for new apps uploaded to the App Store, developers will have until “early 2027” to declare the medical device status for existing apps.
After the deadline (which remains unclear beyond “early 2027”), however, they will no longer be able to submit updates for those apps.
To learn more about the announcement, follow this link.
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