01
Tell us what it does
Describe each software function, who uses it, and what it’s intended to do.
MADE FOR DIGITAL HEALTH BUILDERS
Medical device
or not?
Let’s find out.
Could your health software be a medical device?
Explore US, EU and UK perspectives
with a free, provisional software check.
Free to use. No payment required.
Is my software a medical device?The information on this site is public. The check is currently limited to approved testers and requires Google sign-in.
Built something in health?A clearer path forward.Without the regulatory rabbit hole.✦++
d?SOFTWARE QUALIFICATION•••
Find your starting point.
One software function.
Three regulatory perspectives.
🇺🇸United StatesFDA
🇪🇺European UnionEU MDR / IVDR qualification
🇬🇧United KingdomMHRA · GB screening
Transparent rules. Clear next steps.
Built around official guidance.
Designed to make it approachable.
FROM “MAYBE” TO A NEXT STEP
Less guesswork. More direction.
A few thoughtful questions.
A practical starting point for your journey.
02
See the bigger picture
Follow a transparent, rule-based check across the US, EU and UK.
03
Know your next step
Explore the reasoning, save your result, or request an expert review.
Free medical device software screening.
DeviceOrNot helps health-software builders explore whether each software function may qualify as a medical device. Start with your intended purpose and claims, then see provisional US FDA, EU MDR / IVDR and UK MHRA perspectives with reasoning and source links.
Often called Software as a Medical Device (SaMD) screening, this is an educational starting point before expert review. The current release is restricted to manual testing.
Regulatory questions? Explore the FAQA clearer starting point.
Get practical context before you make your next regulatory decision.
How do I know whether my product is a medical device?
Start with what the product is intended to do, not the technology behind it. Identify the medical purpose, intended users, patient population and decisions supported by the output. An app, an AI model and a physical product can each fall within device regulation. Definitions and exclusions differ by market, so a conclusion in one country does not settle the others.
Explore this topic and official sourcesCan I avoid device regulation by calling my app a wellness product?
The label alone does not settle the question. A genuine general-wellness function may be outside the device definition or within a specific low-risk policy, depending on its claims, risks and the applicable jurisdiction. Disease-specific diagnosis or treatment claims need closer scrutiny. FDA’s January 2026 wellness guidance concerns a US policy; it is not a global exemption.
Explore this topic and official sourcesDoes having a clinician review the AI output make the software exempt?
Not automatically. A clinician in the workflow is one fact, not a universal exclusion. For US clinical decision support, assess all the applicable statutory non-device CDS criteria using the current FDA guidance. Whether the professional can independently review the basis for a recommendation matters. Do not apply that conclusion automatically in the EU or to software intended for patients.
Explore this topic and official sourcesA starting point, with the limits made clear.
Qualification can be nuanced. This restricted release is approved for manual testing. Results are provisional and include reasoning and sources; regulatory validation remains pending.
Your next step starts here.
Start my free device checkEducational estimate. Not an official determination or regulatory advice.