Apple Mandates Medical Device Disclosures on US EEA UK Apps Today
Starting today, developers of health apps in Europe and North America must declare if their software qualifies as regulated medical devices. The new App Store policy requires product pages to explicitly display this status for transparency across the United States, European Economic Area (EEA), and U.K., marking Apple's continued expansion into healthcare technology regulation. This update ensures customers can immediately identify whether an application is subject to specific regulatory oversight rather than general wellness guidelines.
Key Points
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1Apple is introducing new App Store policies requiring health app developers to disclose if an application qualifies as a regulated medical device.
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2This disclosure requirement applies specifically in the United States, European Economic Area (EEA), and UK starting today for apps meeting specific criteria regarding independent or connected functionality. Developers must register with relevant authorities by early 2027.
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3"Regulated" status is defined based on whether an app functions independently as a medical device or connects to one.
Developments
The App Store will now label apps as regulated medical devices in the EU, UK, and US if they meet specific criteria such as being categorized under Health & Fitness or Medical Information with frequent treatment labels; developers must then provide region-specific registration details like FDA Owner/Operator numbers for these labeled applications.
Starting today, developers of Health & Fitness or Medical apps in the US, UK, and Europe must declare if their applications are regulated medical devices on Apple's product pages by providing relevant regulatory information via App Store Connect. While new uploads require immediate compliance with this disclosure rule set to begin early 2027 for existing titles after which updates will be blocked until then remains unclear beyond 'early
The App Store will require developers distributing apps in the EEA, UK, or US that function as standalone diagnostic tools (or fall under specific Health & Fitness/Medical categories) to declare their Regulated Medical Device status. While new compliant applications must provide this information immediately by early 2027 for updates and distribution thereafter