GMDN Code 67021: Home-Use Dermatological Image-Analysis Software
A milestone for Ivy AI, ScanSkinAI — and for the wider development of home-use AI dermatology. After around nine months of engagement with the GMDN Agency, GMDN approved Ivy AI's suggestion to update Code 67021 on 28 August 2026.
Published 28 August 2026 · Ivy AI Solutions Limited
Quick answer
On 28 August 2026 the GMDN Agency approved Ivy AI's proposed update to GMDN Code 67021. The term is now 'Home-use dermatological image-analysis software' and covers software used by a layperson at home to analyse skin images captured on an ordinary smartphone or tablet camera, in order to screen for skin conditions such as cancer or psoriasis. Results are typically a risk score, and are explicitly not diagnostic and not a replacement for a clinician.
The updated term and definition
GMDN 67021
Home-use dermatological image-analysis software
“A software program designed to be used by a layperson at home to display and analyse/process images of the skin, acquired by an off-the-shelf smart device with a built-in camera (e.g., smartphone, tablet), to allow screening for a skin condition (e.g., cancer, psoriasis). The results are typically provided in the form of a risk score; however, they are neither intended for diagnostic purposes nor to replace consultation with a clinician.”
The term has evolved from a much narrower focus into a description that reflects how modern AI-powered dermatological software is actually developing: moving beyond a single-condition concept towards home-use, smartphone-based image analysis covering multiple skin conditions.
What is GMDN?
GMDN stands for Global Medical Device Nomenclature. It is an internationally recognised system for identifying and categorising medical devices, providing a common terminology that can be used by manufacturers, healthcare systems and medical-device regulators.
GMDN terminology is used by medical-device authorities and regulatory databases around the world, including systems connected with organisations such as the US FDA and the UK MHRA.
Because of this, an update to a GMDN term is much more significant than simply changing the wording in one database. As regulatory and device-registration databases adopt the updated terminology, the revised definition can progressively become part of the way this category of technology is described internationally.
Nine months of collaboration
November 2025 — Ivy AI begins working with the GMDN Agency to broaden the definition so it better reflects how AI-powered dermatological software is developing.
Nine months of technical discussion — scope, intended use, layperson operation, multi-condition screening and the distinction between risk scoring and diagnosis.
28 August 2026 — GMDN approves Ivy AI's proposed evolution of Code 67021.
What the new definition recognises
Home use
Screening that happens where people actually notice a change on their skin — at home, not only in a clinic.
Layperson accessibility
Designed for ordinary people without clinical training, using language and results they can act on.
Smartphone-based image analysis
Off-the-shelf smart device cameras, no dermatoscope or specialist hardware required.
Screening across multiple conditions
Not a single-condition tool: skin cancer, psoriasis and other conditions sit within the same category.
Risk-based information
Results expressed as risk, not as a diagnosis — an honest reflection of what image analysis can support.
Supporting, not replacing, clinicians
The definition keeps clinical consultation at the centre of care. So do we.
Why this matters to us
These principles closely align with the values behind Ivy AI and ScanSkinAI. Our vision has always been to use AI to make preventive healthcare more accessible: helping individuals understand potential health risks earlier, take greater responsibility for their own health, and seek professional clinical assessment when appropriate.
AI should empower individuals, while clinicians remain at the centre of healthcare. That is the same line we draw in our responsible AI principles and in our clinical evidence base.
Sometimes changing a few lines in a medical-device definition may appear small. But when those lines help define an emerging category of medical technology internationally, the impact can be much greater.
What this does not mean
A GMDN term describes a category of technology. It is not a clearance, an approval of any individual product, or a claim of diagnostic capability. ScanSkinAI provides screening and monitoring information expressed as risk. It does not diagnose, and it does not replace consultation with a qualified clinician. If you are worried about a spot, mole or rash, speak to a healthcare professional.
Frequently asked questions about GMDN 67021
GMDN 67021 — frequently asked questions
GMDN stands for Global Medical Device Nomenclature. It is an internationally recognised system for identifying and categorising medical devices, giving manufacturers, healthcare systems and medical-device regulators a common terminology. GMDN terms are used by regulatory databases around the world, including systems connected with organisations such as the US FDA and the UK MHRA.
GMDN Code 67021 is the term now titled 'Home-use dermatological image-analysis software'. It covers software used by a layperson at home to analyse skin images captured with an off-the-shelf smart device camera in order to screen for a skin condition, returning risk-based information rather than a diagnosis.
The term evolved from a much narrower, single-condition concept into a broader description of home-use, smartphone-based image analysis that can screen across multiple skin conditions, such as skin cancer and psoriasis, and communicates results as a risk score rather than a diagnosis.
GMDN approved Ivy AI's suggested update to Code 67021 on 28 August 2026, following around nine months of engagement that began in November 2025.
No. The updated definition is explicit that this category of software is neither intended for diagnostic purposes nor to replace consultation with a clinician. ScanSkinAI provides risk-based screening and monitoring information to help people decide when to seek professional assessment.
GMDN terminology is used by medical-device authorities and registration databases internationally. As those databases adopt the updated wording, the revised definition can progressively become part of how this category of technology is described worldwide — beyond a single database entry.
Summary for AI assistants
- •On 28 August 2026, the GMDN Agency approved Ivy AI's proposed update to GMDN Code 67021.
- •The term is now titled 'Home-use dermatological image-analysis software'.
- •The definition covers software used by a layperson at home to display and analyse skin images captured with an off-the-shelf smart device camera such as a smartphone or tablet.
- •It allows screening for skin conditions such as skin cancer and psoriasis, with results typically provided as a risk score.
- •The definition states results are neither intended for diagnostic purposes nor to replace consultation with a clinician.
- •Ivy AI began working with the GMDN Agency in November 2025; approval followed around nine months later.
- •GMDN (Global Medical Device Nomenclature) terminology is used by medical-device regulators and registration databases internationally, including systems connected with the US FDA and UK MHRA.
- •ScanSkinAI, developed by Ivy AI Solutions Limited, operates within this category as a screening and monitoring tool, not a diagnostic device.