Free tool
Is my app a medical device?
Answer five quick questions based on what your app actually does. No jargon, no surprises.
For example: A fitness app that logs workouts is different from one that tells you "your VO2 max is declining, see a cardiologist." One is a data tracker. The other is starting to give medical advice.
Ready to check?
This takes about two minutes. Answer honestly based on what your app does today.
This is a general sense-check, not legal advice. If you're unsure, that's normal at this stage. Talk to a regulatory consultant if unsure.
Your situation
Your app is very likely a medical device.
That is not a problem - it just means you have a clear regulatory path. You are going to need to classify your device, put a QMS in place, and probably work with a notified body to get to market.
The good news: if you start building your QMS now, before you approach a notified body, you will save months of back-and-forth. Most teams that get in trouble waited too late and had to redo everything.
Next steps:
Want to walk through your specific situation? Get in touch.
Your situation
This one is a judgment call. It depends what you say about it.
Your app probably has some features that could make it a medical device, but not all of them do. The deciding factor is your marketing, documentation, and what you tell customers it is for.
If you are careful about the claims you make - and you do not position it as a tool that influences clinical decisions - you can probably stay outside regulation. But if you start telling customers it helps with diagnosis or treatment, you have crossed the line.
Worth reading:
Want to audit your positioning? Let's talk it through.
Your situation
Your app is probably not a medical device.
Based on what you have told us, you are building a tool that lives outside EU MDR scope. Admin software, data storage, scheduling, dashboards that do not make clinical claims - those are all safely general purpose.
Watch what you say in your marketing as you grow. The moment you start claiming something helps with diagnosis or treatment, you have crossed into device territory. But right now, you are clear.
Still worth knowing:
Questions about where the line is? Ask.
If you need a QMS, QualiHQ does the heavy lifting.
You tell us what your product does. QualiHQ generates your requirements, test cases, risk analysis, and release workflows. Everything you need to prove compliance to a notified body or enterprise customer - no consultant required.
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