Welcome to my Digital Health Regulatory Pathways Master Class series. This series breaks down the core concepts every founder should understand about US and EU regulatory pathways, from what qualifies as a medical device to how risk classification affects your timeline, cost, and market strategy.
You’ve landed on #2 of this series, where I explain the very definition of a regulated medical device in the US and the EU.
If you’re a digital health founder building software or AI-enabled tools, you may be wondering:
“Is my product even considered a medical device?”
The answer to this question determines whether you need FDA approval or notification, only product registration and listing, or a Notified Body review. It also determines what the expectations are for the clinical evaluation of your product and what documentation will be required.
Let’s break down what actually counts—and what doesn’t.
According to both the FDA and EU MDR, a medical device is any product (including software!) that is:
“Intended by the manufacturer to diagnose, prevent, monitor, treat, or alleviate disease or injury—or to affect the structure or function of the body.”
That includes everything from physical tools (like tongue depressors) to complex software systems (like AI diagnostic tools).
Important: Even if your product looks like harmless software, if it directs medical decisions or supports diagnosis—it may be regulated.
Many digital health founders assume software = low risk. But if your software is involved in clinical decision-making, monitoring health, or triggering medical alerts, regulators see it differently.
Examples of software that are considered medical devices:
Examples that aren’t:
If your product is purely for wellness, administrative use, or lifestyle improvement, you might be off the hook. But as soon as it crosses into diagnostic, therapeutic, or monitoring territory, and is targeted toward disease as opposed to general wellness, it likely qualifies as a regulated medical device.
Once your product qualifies as a medical device, everything changes. Here’s a sample of what you can expect:
|
Factor |
Without Medical Device Status |
With Medical Device Status |
|
Legal Restrictions |
Few to none |
Must comply with FDA or MDR to be marketed |
|
Go-to-Market |
Fast and flexible |
Requires pre-market approval, notification, or compliance with regulations |
|
Documentation |
Optional |
Mandatory technical files |
|
Investor Readiness |
Lower bar |
Stronger with regulatory plan |
|
Risk Class |
Doesn’t apply |
Determines pathway, cost, and clinical trial requirements |
Skipping this determination or assuming you’re exempt can lead to:
Ask yourself:
If the answer to any of these is yes, you’re probably in medical device territory—and should be thinking now about regulatory pathways.
A handy FDA quick check tool can be found here: Digital Health Policy Navigator
An equivalent for the MDR can be found here: Is Your Software a Medical Device?
Now that you know what counts as a medical device, the next step is to understand how the U.S. and EU regulate those devices differently.
In the next post, we’ll walk through:
Don’t miss it—especially if you’re debating whether to launch first in the U.S. or EU.
Really. If you have a question, submit it through this form. I will try my best to respond within a business day. Good questions will get featured on my FAQs list.
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