Overview
- Apple, which announced the change Thursday, now requires new Health & Fitness or Medical apps in the U.S., U.K., and EEA to declare whether they are regulated medical devices.
- Existing apps must file a status by early 2027 or lose the ability to ship updates.
- The rule also covers apps flagged in the age rating questionnaire for frequent medical or treatment references, and developers must enter the status and related details in App Store Connect.
- Product pages for labeled apps will show an EU Manufacturer SRN or an FDA Owner/Operator Number, a URL for instructions, a use statement, and safety warnings, and Apple says the U.K. does not require a corresponding number.
- Apple and reporters note the label confirms regulatory compliance rather than proof of clinical results, which helps users sort regulated tools as health software moves deeper into medical care.