App Store to Display Regulated Medical Device Status for Relevant Apps

TL/DR –

Apple has announced that App Store product pages will display if an application is a regulated medical device. This will apply to apps in the European Economic Area, United Kingdom, and United States, and such apps may require authorization from bodies like the FDA. New apps must already declare this status, while existing apps need to provide a status by early 2027 or they will not be allowed to submit updates.

Apple App Store to Display Medical Device Status

Apple has announced that its App Store will now indicate if an app is a regulated medical device. This update applies to the European Economic Area (EEA), United Kingdom, and United States.

Apple explains that these medical device apps can function independently or as part of a system for medical purposes such as disease diagnosis, prevention, monitoring, and treatment. Some apps may need authorization from regulatory bodies like the Food and Drug Administration.

App developers releasing Health, Fitness, or Medical apps in the EEA, UK, or U.S. need to provide a regulated medical device status in App Store Connect, along with relevant regulatory information. Apps frequently referring to medical or treatment information must also provide this status.

This status requirement applies to new apps meeting these criteria as of today. Existing apps must provide a status by early 2027, and those who fail to declare a status will not be allowed to submit app updates.

App Store pages for regulated medical devices will feature an EU Manufacturer SRN or FDA Operator Number, a URL with use instructions, a use statement, and safety information. More details are available on Apple’s developer website.

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