SaMD vs. Non-Regulated Health Software

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

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

1. Write your intended purpose in one sentence.
2. Check every claim in your UI, onboarding, and marketing against it.
3. Map it to FDA and, if you sell in Europe, MDR Rule 11.
4. 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.