Apple is introducing a new transparency requirement for health and medical apps on the App Store in the European Economic Area, United Kingdom, and United States. Starting today, developers must declare whether their software functions as a regulated medical device, with that status displayed directly on the app’s product page.
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The requirement applies to apps categorized under Health & Fitness or Medical, as well as any app marked as containing frequent references to medical or treatment information in its age rating questionnaire. If an app meets either condition, developers must provide its regulatory status in App Store Connect. Apps that do not provide medical functionality or use health data to support such features can simply select “No.”
For apps that qualify, Apple defines regulated medical device software as those used for diagnosis, prevention, monitoring, and treatment of diseases or physiological conditions. This includes standalone apps as well as those that interface with external medical hardware.
New app submissions that meet these criteria must include the declaration immediately to distribute in the EEA, UK, or US. Existing apps have until early 2027 to provide a status. After that point, developers who have not submitted the required information will no longer be able to release app updates.
When an app is declared as a regulated medical device, developers must provide specific regulatory information. For the US, this includes an FDA Owner/Operator Number, while EU distribution requires an EU Manufacturer SRN aligned with an EUDAMED listing. Apple notes that a corresponding number is not currently required for the UK.
Developers must also provide a URL with the app’s instructions for use, along with an intended use statement and detailed safety information. This includes warnings, precautions, and contraindications taken directly from official labeling. For US apps, this section can also include instructions on how users can report adverse events to the FDA.
Once submitted and verified, this information will appear directly on the app’s App Store listing, giving users clearer visibility into an app’s regulatory status before downloading.
