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MDR classification for skin-analysis software, what MDCG 2019-11 means for the practice

In June 2025 the Medical Device Coordination Group (MDCG) published MDCG 2019-11 Rev.1 and tightened the rules on software classification under MDR and IVDR. We walk through what this concretely means for software around skin-analysis devices, where the class boundaries sit and what practices should check before deploying.

Updated 25 May 2026 · 7 min read

Anyone deploying software for skin analysis in a dermatology practice falls under the user duties of medical-device law. The class of the software is set by the manufacturer based on MDR and its accompanying guidance. MDCG 2019-11 is the central interpretation aid for software, Rev.1 published in June 2025. We walk through the most important points for skin-analysis software.

What MDCG 2019-11 is and does

The Medical Device Coordination Group (MDCG) is the EU advisory body on MDR and IVDR interpretation. The guidance MDCG 2019-11 is titled "Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 — MDR and Regulation (EU) 2017/746 — IVDR". It helps software manufacturers answer two questions: is the software a medical device at all (qualification), and if so, in which class does it fall (classification). The guidance is not statute, but in the EU it is binding interpretation for notified bodies and supervisory authorities.

Rev.1 from June 2025 has, among other things, sharpened the scope, strengthened the importance of the "intended purpose" formulation and clarified Rule 11 for disease-prevention software. For the practice this means: the intended-purpose wording in the manufacturer's handbook is classification-decisive, not the marketing material.

Hardware scanner vs report software

Deploying 3D skin analysis in the practice brings two software layers together that must be classified separately:

  • Device software (on the skin scanner): the capture software and embedded algorithms that compute wrinkle depths, pigment counts and score values. Runs on the manufacturer's device and is certified with the device as a medical product. On Isemeco devices Class I (purely optical imaging).
  • Report software (on a separate server): the software that turns the raw values into the patient-readable report. This is where Dermalia sits. This software qualifies as a medical device only if it uses the computed values for diagnosis, prediction, prognosis, treatment guidance or disease-course prediction.

When report software becomes MDSW

MDCG 2019-11 lists several criteria that make software Medical Device Software (MDSW). The most important for our context:

  • Processing of medical data to generate new information: when the software derives diagnostic, therapeutic or prognostic statements from raw data. Plain visualisation of the values delivered by the device is not MDSW.
  • Diagnostic, therapeutic or prognostic purpose under Art. 2 MDR: when the intended purpose explicitly aims at diagnostic support, therapy decision or prognosis of disease development. If the intended purpose is limited to "visualisation" and "report presentation", the software is not MDSW.
  • Information about physiological state: when the software directly interprets physiological measurement values (e.g. wrinkle depth as an indicator of skin aging in a clinical sense). Grey area, further illuminated in Rev.1.

Dermalia positions itself in the intended purpose as a report-presentation layer: we compute no diagnostic values ourselves, we transport the score values delivered by the Isemeco device into a patient-readable representation. AI Q&A and smart recommendations are explicitly non-diagnostic (refusal detection for emergency keywords, no treatment suggestion by the software).

Class boundaries under Rule 11

MDR Annex VIII Rule 11 classifies software that drives diagnostic or therapeutic decisions. The class boundaries simplified:

  • Class I: Software for pure information storage, simple archival or visualisation functions without diagnostic evaluation. Plain report presentation typically falls here.
  • Class IIa: Software supporting diagnostic or therapeutic decisions where a wrong decision cannot lead to serious health damage or death. Diagnostic-supporting skin-analysis software falls here.
  • Class IIb: Software whose decision can result in serious health damage. Example: software flagging melanoma suspicion and carrying a biopsy decision.
  • Class III: Software whose decision is life-critical. Example: AI-supported tumour-detection software whose output carries a direct treatment decision.

Practical implication: anyone deploying skin-analysis software that explicitly flags suspicion diagnoses like "suspected melanoma" should look closely at the manufacturer's class certification. Class I would be too low here, this would likely be Class IIa or IIb.

What practices should check before deployment

  • Manufacturer declaration of conformity: which class, which notified body, when issued. The declaration of conformity is a mandatory part of the device file.
  • Intended purpose in the manufacturer's handbook: what does the manufacturer say the software is for. If the practice uses it for something else (e.g. diagnostic software repurposed for therapy guidance), responsibility shifts to the practice.
  • Lifecycle updates: MDR requires the manufacturer to deliver security updates across the lifetime. End of support equals a risk assessment.
  • Device-log entry: Software versions are tracked like hardware updates. Who deployed which version when is documented in the device log.

Dermalia position

We have completed an internal MDR self-assessment (as of May 2026) that classifies the software as a non-medical report-presentation tool. The final regulatory assessment in the concrete case rests with a specialist medical-law attorney or an external notified body. We provide the documentation, we do not decide the classification for your practice. The self-assessment document sits in the repository under docs/compliance/mdr-self-assessment.md and can be released as PDF on request.

Sources and further reading

As of May 2026. This article is orientational professional information, not a regulatory assessment in the individual case. The final classification of your practice-software combination belongs in the hands of a specialist medical-law attorney or a notified body.

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