Your MedTech Compass result
Looks like Class IIa to IIb
AI-assisted dermatology triage app for suspected melanoma. Indicative under Rule 11, and not validated: the breakdown below shows how the answers spread across the possible classes.
AI's read (indicative, not validated)
Why? Class IIa
Triage support that informs a clinician's decision, at the severity described, is consistent with Rule 11's default software tier.
Why? Class IIb
If the output is read as detecting possible melanoma rather than prioritising a referral, Rule 11 points at the higher tier for decisions with serious consequences, and the wording leaves that open.
Why? Class I
Only plausible if the app were repositioned as general wellness or pure documentation, which the stated purpose contradicts.
Why? Class III
Would need the output to drive decisions with potential for death or irreversible deterioration, which triage-to-specialist referral does not on its own.
IIa leads because the decision was described as lower-severity support, and the remaining weight sits on IIb because the intended purpose straddles informing a decision and flagging suspected disease. Settling that one sentence, and whether a clinician always stays in the loop, would narrow this the most.
An AI estimate of how your answers spread across the classes, with a short reason for each. It is AI-generated and indicative, and it does not decide your class.
Conservative by design. When your answers leave a rule ambiguous, the AI leans toward the higher-risk class rather than the more convenient one. An expert review confirms or corrects the class against your full evidence.
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Open Classification toolRoute to market
Indicative route
Annex IX: full QMS assessment with technical-documentation sampling by a notified body.
For the EU, the EU route above is the reference point.
The gap map
Your answers point at Rule 11; confirm the class with an expert before it anchors your file. The percentage-per-class breakdown on this report shows how your answers spread across the possible classes; treat it as an estimate, not a determined fact.
A full technical documentation package under MDR Annex II/III, sized to the notified body's technical-documentation assessment for this class. You already hold an intended purpose statement, a risk file, and software documentation, which are three of the pieces the file is built from; the gap is the structure and the rest of the content around them.
Because you said you already hold an intended purpose statement, a risk file, and software documentation.
A clinical evaluation report, typically literature-based unless the device is genuinely novel.
You are already building the system, so this is a plan item rather than an open gap: at this class the notified body assesses it under Annex IX before certifying the device, so its completion sits on the critical path and its timing should track your market date.
Because you said your quality management system is being built.
Software that involves AI/ML needs an EU AI Act risk-tier position alongside its MDR class: the two run in parallel, not one after the other.
What we'd do first
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