The further Apple dives into medical technology, the more it will have to deal with regulators. Now, the App Store will label apps that meet select criteria for medical devices in the US, EU, and UK.

Developers that offer apps with medical uses or connect to medical devices have to be registered with the FDA in the US. Similar regulations exist in the UK and EU, and now there's a way for developers to label their apps as a regulated medical device in the App Store.

According to Apple's developer documentation, an app must meet three criteria to get the label. First, the app must be available in the EU, UK, or US and may or may not require registration or authorization from regulatory bodies.

In the App Store, those apps must have a primary or secondary category of Health & Fitness or Medical. Also, if the age rating questionnaire section labels "Medical or Treatment Information" as "frequent," then they fall into the requirements for a label.

The FDA defines medical devices rather widely with its website stating: "Medical devices range from simple tongue depressors and hospital gowns to complex programmable pacemakers and robotic surgical systems."

Apple says this specifically about regulated medical devices:

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.

Once a developer has determined if their app qualifies for the regulated medical device label, they'll have to provide additional information to Apple. The information required varies by region.

  • 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.

These labels are required by regulatory laws, but they'll also benefit users. They should help those browsing the App Store distinguish between true medical or health apps versus ones operating outside of regulatory bodies.

However, a regulatory label doesn't guarantee the device or app works — it just means that they meet regulatory requirements. It is always important to understand what such products are providing and how you can use them.

As always, consult your doctor before engaging with anything that could affect your overall health. This is going to become increasingly important as Apple broadens its involvement in health and fitness.