To provide additional transparency to customers, the App Store will now show whether an app is a regulated medical device on its product page in the European Economic Area (EEA), United Kingdomor United States. Regulated medical device applications are those that operate alone or as part of a system for a variety of medical purposes, including the diagnosis, prevention, monitoring and treatment of diseases and physiological conditions. These applications may require registration or authorization from regulatory bodies, such as the US Food and Drug Administration (FDA).
If you distribute in the EEA, UK or US and your app meets any of the following criteria, you will need to provide a regulated medical device status in App Store Connect, along with relevant regulatory information such as contact details and safety information:
- Your primary or secondary category is Health and Fitness or Medicine.
- It is flagged for containing frequent references to medical or treatment information in the age rating questionnaire on App Store Connect.
Starting today, this status is required for new apps that meet any of the above criteria to be distributed in these regions. Existing apps distributed in these regions that meet any of the above criteria must provide a status by early 2027. However, if you have not declared your app’s status by early 2027, you will no longer be able to submit app updates. If your application is not a regulated medical device, you can select No.
Find out more about providing a regulated medical service. device status
