Apple has also responded to the requirements set forth in MDCG 2025-4,“Guidance on the Safe Making Available of Medical Device Software (MDSW) Apps on Online Platforms”: In the European Economic Area (EEA), the United Kingdom, and the United States, the product page will now indicate whether an app is considered a regulated medical device.
This results in specific obligations for developers. If such an app is available in the regions mentioned, the status “regulated medical device” must be specified in App Store Connect. In addition, relevant regulatory information must be provided, such as contact details and safety notices.
The disclosure requirement applies if at least one of the following criteria is met:
- The app is classified in the primary or secondary category“Health & Fitness” or “Medicine.”
- The age rating questionnaire indicates that the app contains frequent references to medical or treatment-related content.
For new apps, this requirement is now mandatory for distribution in the affected regions. Existing apps must update their status by early 2027. If this deadline is not met, no further updates may be submitted.
If an app is not classified as a regulated medical device, you can indicate this by selecting “No” in App Store Connect.
Apple provides more information on this topic at this link: Update on regulated medical device apps in the European Economic Area, the United Kingdom, and the United States – Latest News – Apple Developer