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App Store Connect / Manage app information / Declare regulated medical device status

Manage app information

Declare regulated medical device status

To provide additional transparency on the App Store, apps that are available in the European Union (EU)/European Economic Area (EEA), United Kingdom (UK), or United States (US), and that also meet either of the criteria listed below must indicate whether they’re regulated medical device with respect to each region’s regulatory authority or body responsible for the governance and compliance of medical devices.

  • Have a primary or secondary category of Health & Fitness or Medical

  • Have indicated your app contains “frequent” in the Medical or Treatment Information field in the age rating questionnaire in App Store Connect

Regulated medical device apps are used for a range of medical purposes, including diagnosis, prevention, monitoring, and treatment of diseases and physiological conditions. They may function on their own or by interfacing with medical device hardware. These apps may require registration or authorization from regulatory bodies such as the U.S. Food and Drug Administration (FDA). Learn more about regulated medical devices in the EU/EEA, in the UK, and in the US.

If your app doesn’t provide any health or medical features, or access health data to support non-health features, you should select No, to declare that your app is not a regulated medical device.

If your app is a regulated medical device, you'll need to provide the following information. In some instances this'll require obtaining authorization or completing registration from the region’s regulatory authority. This information will display to customers on your App Store product page.

  • EU Manufacturer SRN or FDA Owner/Operator Number: This should align with your EUDAMED listing and/or FDA establishment registrations. This isn't required for the UK.

  • Instructions for use URL: The URL containing the user guide or instructions for use for your app, hosted on your website.

  • Use statement: For the US, this is your indications for use statement. For the EU/EEA and UK, this is your intended purpose or intended use statement.

  • Safety information: Provide relevant warnings, precautions, and contraindications as they appear in your labeling. For the US, this is also where you can include a statement about how users can report a problem to the FDA such as "To report a problem or adverse event to the FDA, visit www.fda.gov/safety/report-problem-fda".

How to know if your app is a regulated medical device

  • Your app was cleared or approved by the US FDA

  • Your app is registered on the US FDA medical device database

  • Your app was issued a CE mark by an EU-based notified body for compliance with the EU Medical Device Regulation (MDR) or Medical Device Directive (MDD)

  • Your app was issued a UKCA mark by a UK-based approved body for compliance with the UK Medical Device Regulations

  • You’ve self-certified your app under the EU Medical Device Regulation (MDR) or Medical Device Directive (MDD)

  • You’ve self-certified your app under the UK Medical Device Regulations

Required role: Account Holder or Admin. View role permissions.

Declare regulated medical device

  1. In Apps, select the app you want to view.

  2. In the sidebar, under General, click App Information.

  3. Under App Store Regulations & Permits, click Declare Regulated Medical Device.

  4. Indicate if your app is a regulated medical device in any country or region.

    • If you select No, click Save and you are done.

    • If you select Yes, continue with step 5.

  5. Select which countries your app is a regulated medical device in and click Save.

  6. Complete the required information for each country or region where your app is considered a regulated medical device.

    • Verify your contact information that will appear on the App Store. If this information is inaccurate, you’ll need to update it in the Business section of App Store Connect.

    • Enter your EU Manufacturer SRN or FDA Owner/Operator Number for the US as applicable

    • Provide the instructions for use URL, use statement, and safety information. If you wish to localize this information, you can add the required details in each localization from the dropdown menu.

  7. Once all the information has been completed and verified, click Save, and the information will go live on the App Store within 24 hours. If the app is not yet approved to be live, the information will go live once the app is approved and released to the store.

Update your regulated medical device declaration

You can click Edit next to the Regulated Medical Devices section to change your declaration for your app or to add or remove countries and regions.

If you have declared that your app is a regulated medical device and need to update the information provided, you can click Edit next to the country or region that needs to be updated in order to make the necessary changes.

You can also manage your contact information by going directly to the Business section and selecting Regulated Medical Devices under the Compliance section.

Updated information will be reflected on the App Store within 24 hours of saving the changes.

Regulated medical device statuses

Status

Definition

Yes

You've declared your app is a regulated medical device in this country or region and entered the required information.

No

You've indicated that your app is not a regulated medical device in this country or region.

Missing Info

You've indicated that your app is a regulated medical device in this country or region, but have not completed the required information.
Related App information Required, localizable, and editable properties