Apple has started adding a new layer of transparency to the App Store by labeling apps that qualify as regulated medical devices, which directly affects how users understand health-related apps across the US, UK, and European markets. This change comes as Apple continues to expand deeper into health technology, where stricter regulatory oversight already shapes how apps operate and how developers bring them to market.
According to Apple’s developer website, developers who build apps for medical use or connect their apps to medical hardware must now declare whether their apps meet regulated medical device standards in supported regions. This requirement applies to apps listed under Health and Fitness or Medical categories, and also to those that frequently include medical or treatment-related content in their age rating questionnaire.
“Regulated medical device apps are used for a range of medical purposes, including diagnosis, prevention, monitoring, and treatment of diseases and physiological conditions. They may function on their own or by interfacing with medical device hardware.” — Apple
Developers must provide this
Once a developer confirms that their app qualifies, they must submit detailed regulatory information that will appear directly on the App Store listing, which gives users clearer insight into how the app works and what standards it meets. This includes identification numbers like the FDA Owner or Operator Number or EU Manufacturer SRN, along with a clear use statement that explains the app’s intended medical purpose.
At the same time, developers must include a link to instructions for use, hosted on their own website, and provide safety information that outlines warnings, precautions, and possible risks associated with the app. In the US, developers can also include guidance on how users can report issues directly to the FDA.
These labels help users distinguish between apps that meet regulatory standards and those that do not, which becomes increasingly important as more apps claim to support health tracking, diagnosis, or treatment. Apple makes it clear that a regulatory label confirms compliance with rules, but it does not guarantee effectiveness, so users still need to understand how each app works before relying on it.
Developers must comply with this requirement for new apps starting now, while existing apps have until early 2027 to declare their status, after which Apple will block updates for apps that fail to provide the required information.
