Apple mandates medical device disclosure for health apps across key markets

Apple has introduced a new App Store policy requiring certain health-related apps to disclose whether they qualify as regulated medical devices, a move that affects developers operating in the United States, United Kingdom, and the European Economic Area.

Under the updated rules, apps that fall within the Health & Fitness or Medical categories—or those flagged for containing frequent references to medical or treatment information—must declare their regulatory status through App Store Connect. The requirement applies immediately to newly submitted apps, while existing apps have until early 2027 to comply.

As part of the change, App Store product pages in the affected regions will display whether an app is considered a regulated medical device. These apps may include software used for diagnosis, monitoring, prevention, or treatment of medical conditions, either independently or as part of a broader healthcare system.

Developers will also be required to provide supporting regulatory details, which may include identifiers such as a U.S. Food and Drug Administration (FDA) operator number or an EU manufacturer registration number, along with safety information and usage guidance.

The policy introduces a phased compliance timeline. While new apps must meet the requirement upon submission, developers of existing apps have until early 2027 to declare their status. After that point, apps that have not provided the required information will be restricted from receiving updates.

The change effectively links regulatory transparency to ongoing app maintenance, increasing pressure on developers to assess whether their software falls under medical device classifications.

The update reflects increasing scrutiny of digital health tools and their classification within regulatory frameworks. By requiring developers to explicitly state whether their apps are regulated, Apple is aligning App Store disclosures more closely with existing healthcare oversight mechanisms in major markets.

The policy also signals a shift toward clearer differentiation between general wellness apps and those that may carry clinical or therapeutic implications, as regulators continue to evaluate the role of software in healthcare delivery.