AI & TechnologyApp Store Medical Device Status Declaration: 2027 Deadline

If your app is in Health & Fitness or Medical, or you told Apple it has frequent medical or treatment information, and it's available in the EEA, UK or US, you have to declare in App Store Connect whether it's a regulated medical device by "early 2027", or you won't be able to submit updates. Apple gives no exact date, so I'd do it now. It takes a few minutes if the answer is No.

I checked each one on October 19, 2026. The facts come from Apple's March 26, 2026 news post and the App Store Connect Help page, as shown in the sources. Apple can change a date, so open the linked pages before you plan around it.

Disclosure: App369 is my studio. I build and fix Flutter and Firebase apps, and the last section mentions what I sell. Apple doesn't pay me for anything on this page. This is not legal or regulatory advice.

The dated timeline

The post says: "Existing apps distributed in these regions that meet either of the criteria above must provide a status by early 2027." It adds: "However, if you haven't declared your app's status by early 2027, you'll no longer be able to submit app updates."

The pages I read say nothing about live apps being removed. The stated consequence is blocked updates. That still matters, because a blocked update is also a blocked security fix or iOS compatibility release. For the other dated iOS requirement next year, see the iOS 27 SDK requirement.

Which apps and which regions

Apple's help page says the requirement applies to apps that are available in the EU/EEA, the United Kingdom or the United States, and that also meet either of two criteria:

• The app has a primary or secondary category of Health & Fitness or Medical.
• You indicated that your app contains "frequent" Medical or Treatment Information in the age rating questionnaire in App Store Connect.

The second criterion is easy to miss. A fitness app in the Health & Fitness category is caught by the first one. An app in another category, say Lifestyle, can be caught by the second if you answered "frequent". If you haven't looked at your age rating answers since Apple's update, my guide to the age rating questions shows where that field lives.

I'd treat the three regions separately. Apple asks you to indicate whether the app is a regulated medical device "with respect to each region's regulatory authority", and the declaration lets you choose the countries or regions where the answer is Yes.

What "regulated medical device" means in Apple's help text

Apple's definition: "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)."

The news post uses similar wording and says such apps "function on their own or as part of a system".

Apple lists indicators that an app is a regulated medical device:

• Cleared or approved by the US FDA
• Registered on the US FDA medical device database
• Issued a CE mark by an EU-based notified body under the EU MDR or MDD
• Issued a UKCA mark by a UK-based approved body under the UK Medical Device Regulations
• Self-certified under the EU MDR or MDD
• Self-certified under the UK Medical Device Regulations

For the rules themselves, Apple links to the European Commission's medical devices sector page, GOV.UK's Regulating medical devices in the UK and the FDA's medical devices pages. Those are the regulators' own entry points. I'm pointing to them and not summarizing them, because I'm not qualified to say how a regulator would classify your app.

What the declaration asks

Apple says to select No if your app "doesn't provide any health or medical features, or access health data to support non-health features". In the steps, selecting No and clicking Save completes the process.

If you select Yes, you pick the countries or regions and then fill in, per region:

For the US, Apple says the safety information can also include a statement such as "To report a problem or adverse event to the FDA, visit www.fda.gov/safety/report-problem-fda." You can add localized versions from a dropdown. Contact information is managed in the Business section, under Regulated Medical Devices in Compliance.

Where to click

1. In Apps, select the app.
2. Under General, click App Information.
3. Under App Store Regulations & Permits, click Declare Regulated Medical Device.
4. Say whether the app is a regulated medical device in any country or region.
5. If Yes, select the countries or regions, complete the fields and click Save.

The required role is Account Holder or Admin. To change it later, click Edit next to the Regulated Medical Devices section. The status shown per region is Yes, No, or Missing Info, which means you declared Yes but the required information is incomplete.

My advice: if you run several apps, check each one. The declaration is per app, and an app you forgot is the one that blocks your next update.

How to answer if your app is a general wellness app

Here I have to be careful. Apple's pages I read don't use the phrase "general wellness" and don't say where that line falls. Apple gives you its definition and the indicator list above, and tells you to select No if the app has no health or medical features.

So for an app like a habit tracker, a step counter or a meditation timer, the question to ask yourself is whether it does anything in Apple's definition: diagnosis, prevention, monitoring or treatment of diseases and physiological conditions. If it clearly doesn't, and you hold none of the clearances, marks or registrations on Apple's list, No is the answer Apple's definition points to. Apple's page doesn't say how a step counter or habit tracker with health features should be classified, so that part is my reading.

If the app is in a gray area, for example it reads heart rate and flags irregular readings, it suggests what to do about a symptom, or its store text talks about a condition, don't guess. Ask a regulatory adviser who knows medical devices in the regions where you distribute. This is not legal or regulatory advice, and I can't tell you how a regulator would classify your app.

My advice: whatever you answer, make your store text, in-app copy and the declaration agree. Apple shows the declaration on your product page, so a description that contradicts it would sit right next to it for readers.

What shows on the product page

Apple's help page says: "This information will display to customers on your App Store product page." That applies to the information you enter when you declare Yes: the SRN or FDA number, the instructions for use URL, the use statement and the safety information, per region.

The news post also says the App Store will show whether an app is a regulated medical device in those regions. I didn't find a page that shows exactly where each item appears, so I haven't described the layout. After you save, Apple says the information goes live within 24 hours, or once the app is approved and released if it isn't live yet. Check your own product page in each storefront afterward.

A checklist for small health app owners and Flutter apps

1. List your apps and check each one's primary and secondary category in App Store Connect.
2. Check the age rating field. Look at your answer for Medical or Treatment Information. "Frequent" puts you in scope even outside the two categories.
3. Check where you're distributed. The requirement covers the EEA, UK and US. If you're in none of them, it doesn't apply to that app, per Apple's help text.
4. Confirm your role. Only an Account Holder or Admin can declare.
5. Decide the answer per region using Apple's definition and indicator list. Write down why.
6. Get advice if unclear. A regulatory adviser, not a developer, decides whether an app is a regulated medical device.
7. If Yes, prepare the content first: SRN or FDA number, a hosted instructions for use page, the use statement and the safety text.
8. Declare, then verify the status reads Yes or No, not Missing Info, and check the product page.
9. Match your metadata. Store description, screenshots, in-app onboarding and any health claims should agree with the declaration.
10. Do it before your next release, not during it. A rejected or blocked submission on release day is a bad time to find a missing field.

For Flutter apps, this is an App Store Connect setting, not a code change. Nothing in pubspec.yaml or your Xcode project carries it. What can change is the app itself: if you use HealthKit through a Flutter plugin or add features that interpret readings, that's a product decision to run past your adviser before the build, not after. If you also ship on Android, the Google Fit to Health Connect guide covers the separate Google deadline, and my healthcare app guide covers the wider build and privacy side.

For every other dated Apple, Google Play and Firebase requirement in 2026 and 2027, see App Store and Google Play deadlines for 2026 and 2027.

Need a hand?

If your Flutter app is stuck on an App Store Connect error, a blocked update or a release pipeline problem, the App Fix Ticket covers it in two fixed-price steps. A $450 Diagnosis gives you the root cause with evidence and a fixed repair quote within 3 business days, credited toward the fix. If you go ahead, the $1,200 Fix takes 5 business days and comes as a pull request. Or send me a short description.