Apple’s regulated medical device status question

Apple announced the requirement in a developer news post dated March 26, 2026, and documents the form itself in an App Store Connect help page. The declaration is not a marketing checkbox — it is a compliance-facing statement, tied to specific regulatory facts, that Apple records as part of your app’s App Store Connect submission for the US, the UK, and the EEA.

What triggers the question

Not every developer sees it. Apple requires an answer from apps distributed in the US, UK, or EU/EEA that also meet at least one of two conditions: the app’s primary or secondary App Store category is Health & Fitness or Medical, or the developer has marked the Medical or Treatment Information field of the age-rating questionnaire as “frequent.” The trigger is store metadata, not a legal determination — it catches apps by category and rating answer, not by an independent read of whether the app is actually a regulated device.

It is not one Yes/No — it is two steps

The declaration flow starts with a single question — whether your app is a regulated medical device in any country or region at all. Answer No, and the form is done. Answer Yes, and Apple asks you to select which countries or regions that applies to, then walks you through the required information for each one you selected. A developer account with Account Holder or Admin access is required to complete it, inside App Information → App Store Regulations & Permits → Declare Regulated Medical Device.

Three status values, not two

Per region, the declaration can land in one of three documented states: Yes means you declared the app a regulated medical device there and completed the required information for it. No means you declared it is not. Missing Info means you declared Yes but have not yet finished the required information for that region — it is a state the form itself documents, not a failure of the process. A Yes that is missing its required fields sits as Missing Info; it does not become a No.

What “Yes” requires, and how the fields differ by region

Four things are asked once you declare Yes for a given country or region:

• EU Manufacturer SRN or FDA Owner/Operator Number — expected to align with your EUDAMED listing and/or FDA establishment registration. Apple’s help page states this is not required for the UK.
• Instructions for use URL — a URL, hosted on your own site, containing the app’s user guide or instructions for use.
• Use statement — Apple names this field differently by region: for the US it is your indications for use statement; for the UK and EU/EEA it is your intended purpose (or intended use) statement. Same underlying idea, region-specific regulatory wording — the content should reflect your actual labeling and claims in each market, not be copied automatically from one region’s field into another’s.
• Safety information — relevant warnings, precautions, and contraindications as they appear in your labeling; for the US, this is also where you can include how users report a problem to the FDA.

What you need before you answer

Answering this honestly starts one layer earlier than the form itself: whether your app actually qualifies as a regulated device in the US, the UK, and EU/NI — three separate legal questions, covered in our companion guide, “Is my app a medical device? US, UK, and EU.” If the answer in a given region is Yes, you then need the registration number that applies, a real instructions-for-use URL, a use statement written in that region’s wording and matched to your actual labeling, and your safety information.

Apple’s own help page states one specific case for choosing No: an app that offers no health or medical features at all, and does not access health data to support non-health features. That sentence describes one clear case — it is not the full test for every app with a health-adjacent feature that still is not a regulated device. Getting that broader judgment right is exactly the work a proper qualification review does.

Why getting it right matters

There are real deadlines behind this. The status has been required for new apps since the March 2026 rollout; existing apps must provide a status by early 2027, and Apple states that developers who have not declared a status by then will no longer be able to submit app updates. None of that is a reason to declare Yes or No hastily — a Yes entered without the required information behind it lands in Missing Info, not a completed declaration, and a No that does not match your app’s actual features and claims is a false statement on a platform compliance form, not a marketing decision.

Sources

• App Store Connect HelpDeclare regulated medical device status
• Apple Developer NewsUpdate on regulated medical device apps — US, UK, and EEA (2026-03-26)

This guide is general information, not legal advice, and not an assessment of your app.