Starting today, certain App Store applications are required to state whether they are classified as regulated medical devices in the US, UK, and Europe. Here are the specifics.
### Developers have until early 2027 to adhere
As stated in a recent post on Apple’s Developer blog, “the App Store will now indicate if an app is a regulated medical device on its product page in the European Economic Area (EEA), United Kingdom, or United States.”
This obligation pertains to apps that fulfill at least one of the following criteria:
– Its main or secondary category is Health & Fitness or Medical
– It’s identified as having frequent references to Medical or Treatment Information in the Age Rating questionnaire in App Store Connect
In such instances, developers will be required to “submit a regulated medical device status in App Store Connect, along with pertinent regulatory details, such as contact information and safety information.”
Apple mentions that while this new rule begins today for new apps uploaded to the App Store, developers will have until “early 2027” to indicate the medical device status for existing applications.
After the deadline (which remains unspecified beyond “early 2027”), however, they will be unable to submit updates for those applications.
To find out more about the announcement, follow this link.