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SaMD vs. Non-Regulated Health Software
October 1, 2026
Software counts as a medical device when you intend it to diagnose, treat, monitor, or guide decisions about a medical condition. General wellness, admin, and plain health information tools usually don't. What decides it is your intended purpose, not how complex or risky the code is. Under the EU's guidance, qualification rests on intended purpose alone.
Side by side
| Aspect | SaMD (regulated) | Non-regulated health software |
|---|---|---|
| What it's for | Diagnosing, treating, monitoring, or informing clinical decisions | Wellness tracking, scheduling, billing, general health info |
| Typical examples | Skin-lesion analysis, insulin dose calculators, symptom checkers that name a likely condition | Step and sleep trackers with wellness claims only, clinic booking, admin portals |
| US (FDA) | Device pathway (510(k), De Novo, or PMA, depending on risk) | Software-only general wellness products are exempt, and non-device clinical decision support is exempt if it meets all four statutory criteria |
| EU (MDR) | Under Rule 11, most qualifying software lands in Class IIa or higher, which brings in a Notified Body | Software with a purely administrative, lifestyle, or wellness purpose isn't medical device software |
| Standards | IEC 62304 (software lifecycle), ISO 13485 (quality system), ISO 14971 (risk) | None required by device law, but privacy and security rules (HIPAA, GDPR) can still apply |
| Paperwork | Clinical evaluation, risk file, technical documentation, post-market surveillance | Normal product testing, with claims kept in line with intended use |
Five quick examples
- A sleep tracker that charts your night and offers lifestyle tips: typically wellness, not a device.
- An app that analyzes skin photos and flags possible melanoma: SaMD.
- Clinic scheduling and billing software: not a device.
- A calculator that recommends an insulin dose: SaMD.
- A symptom checker that says "you may have X": very likely SaMD.
Borderline cases exist, and wording in your marketing and UI can move a product across the line.
What changed recently
- US: On January 6, 2026, FDA replaced its general wellness and clinical decision support guidances. Wearables that estimate things like blood pressure or glucose may now count as general wellness products, if the output is only for wellness, the outputs that resemble clinical values are validated, and nothing names a disease or sets clinical thresholds. Software that alerts clinicians to possible stroke, sepsis, or patient deterioration is still treated as a device.
- EU: MDCG 2019-11 Rev.1 (June 2025) is the current software classification guidance. The Commission proposed changes to Rule 11 in December 2025, but that is a draft. Manufacturers should keep classifying under the current rule.
How to decide, in four steps
- Write your intended purpose in one sentence.
- Check every claim in your UI, onboarding, and marketing against it.
- Map it to FDA and, if you sell in Europe, MDR Rule 11.
- Get a regulatory review before you build, not after. Deciding late means retrofitting a quality system and evidence onto software that already exists.
If you're building something that lands on the regulated side, see how we approach SaMD development.
Last reviewed: October 2026. This is general information, not regulatory or legal advice.
FAQs
What is SaMD in one sentence?
Software that performs a medical purpose, such as diagnosing, monitoring, or guiding treatment, without being part of a hardware medical device.
Is a wellness app a medical device?
Usually not, if it sticks to general wellness claims. Once it diagnoses, names a condition, or sets clinical thresholds, it may be.
Can I launch as a wellness app and add medical features later?
Yes, but adding those features changes your intended purpose. Plan the quality system and evidence before you add them.
If my software isn't a medical device, do I have no obligations?
Device law doesn't apply, but privacy, security, and advertising rules still can.
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