AI Dermatologist (Skin Scanner) - MDR Non-Conformity Complaint


To	Health Products Regulatory Authority (HPRA), Ireland. Medical Devices, Market Surveillance
Subject	Report on the non-conformity of a medical device
Reported device	”AI Dermatologist” (Skin Scanner), ai-derm.com
Manufacturer / operator	IAC Search and Media Europe, Ltd.
Provisions infringed	MDR (Regulation (EU) 2017/745) Articles 10.6, 10.7, 10.11, 20, 27 and 52

MD Watchdog, acting through its Regulatory Affairs team of volunteer quality-management and regulatory-affairs professionals, and on the basis of publicly available information, respectfully submits to the Health Products Regulatory Authority the following report concerning the non-conformity of a medical device, on the facts and grounds set out below.

The application “AI Dermatologist” is placed on the European Union market as a consumer-facing diagnostic device for skin disease, including melanoma, while bearing none of the labelling, identification or conformity assessment that Regulation (EU) 2017/745 (the “MDR”) requires of a device of its risk class. It is offered directly to the public, with no professional supervision, to assess a condition that can be life-threatening.

I. The device and its intended purpose

“AI Dermatologist” is a software solution that uses an artificial-intelligence algorithm to analyse images of skin lesions and return a result to the user. The user uploads an image to the application and, after payment, the application displays the condition it has identified. It is presented and marketed as a “Skin Scanner”.

The operator of the application is IAC Search and Media Europe, Ltd., an Irish company registered under number 373923, with registered office at 10 Earlsfort Terrace, Dublin 2, D02 T380. On the consumer app stores the application is distributed under the developer name “Acina”. It is available at ai-derm.com and can be downloaded from the Apple App Store and Google Play. The website content is independently verifiable through the Internet Archive.

The diagnostic claims

The application’s own marketing makes its diagnostic purpose explicit. The following claims appear on the website and within the application:

Ref.	Claim, as published
C1	”AI Dermatologist can save your life. One of the most dangerous diseases that AI Dermatologist can help identify is skin cancer.”
C2	”Our test can help you detect melanoma.”
C3	”An innovative prediagnostic app helps you monitor your skin health and detect any unusual or alerting skin conditions.”
C4	”Based on growing experience and its own autonomous rules, the AI is able to distinguish between benign and malignant tumors, find risks of human papillomavirus, and classify different types of acne.”
C5	”Experience the revolutionary AI-Dermatologist app, a cutting-edge solution to monitor your skin health and identify any potential skin conditions that require attention.”

The marketing, the diagnostic output presented to the user, and the CE marking discussed in Section III are reproduced in the supporting evidence below.

A disclaimer that contradicts the marketing

Notwithstanding those claims, the application carries a disclaimer, displayed in small print:

The scan result is not a diagnosis. To obtain an accurate diagnosis and a recommendation for treatment, consult your doctor.

This statement is inconsistent with the application’s prominent diagnostic claims and commercial messaging. A disclaimer that contradicts the device’s own marketing does not change its qualification under the MDR; it compounds the risk of misleading users, contrary to the patient-safety objectives the Regulation exists to protect.

Qualification as software as a medical device

On the basis of its stated purpose, “AI Dermatologist” is a medical device, and specifically software as a medical device (SaMD). Article 2(1) MDR defines a medical device as:

any instrument, apparatus, appliance, software […] intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.

The application falls squarely within this definition: the user supplies an image and the application returns the pathology it identifies. The International Medical Device Regulators Forum (IMDRF) likewise defines SaMD as software intended for a medical purpose that performs that purpose without being part of the hardware of a medical device.

II. Risk classification

Under the MDR, devices are classified as Class I, IIa, IIb or III according to their intended purpose and inherent risks, in accordance with Annex VIII. Rule 11 of Annex VIII provides:

Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:

death or an irreversible deterioration of a person’s state of health, in which case it is in class III; or

a serious deterioration of a person’s state of health or a surgical intervention, in which case it is classified as class IIb.

Two factors govern the classification: the seriousness of the condition assessed, and the significance of the information provided. “AI Dermatologist” directly addresses melanoma, a life-threatening condition, and provides information used to decide whether a lesion is benign or malignant. A false result therefore carries an impact that may cause death or an irreversible deterioration of health, which places the software in Class III under Rule 11. The risk-classification table in MDCG 2019-11 (Annex III) is consistent with this analysis: software providing high-significance information that informs a decision in a critical healthcare situation falls at the highest level.

The position is reinforced by the IMDRF framework. IMDRF/SaMD WG/N12 gives, as an example of the highest-risk category, SaMD:

used to provide information by taking pictures, monitoring the growth or other data to supplement other information that a healthcare provider uses to diagnose if a skin lesion is malignant or benign.

IMDRF/SaMD WG/N23 further provides that SaMD intended for lay users in a serious condition, without the support of a healthcare professional, must be treated as SaMD used in a critical situation. “AI Dermatologist” is made available to any member of the public, without medical knowledge and without professional supervision, to assess a potentially fatal condition. For these reasons the device must be classified as Class III, the highest risk class under the MDR.

III. Irregularities and non-conformities

1. No label, no Instructions for Use, and missing language versions

Article 10.11 MDR requires that a device be accompanied by the information set out in Annex I, Section 23, in an official Union language determined by the Member State in which it is made available, and that those particulars be indelible, easily legible and clearly comprehensible to the intended user or patient.

The device carries no product label. None of the mandatory label particulars (the manufacturer’s name and address, the device version, the Unique Device Identifier, the intended-purpose statement, and the relevant warnings and precautions) is available to the user within the application or on the website.

The device is likewise supplied with no Instructions for Use. Annex I, Section 23.4 requires the Instructions for Use to state, among other particulars:

(b) the device’s intended purpose with a clear specification of indications, contra-indications, the patient target group […] and of the intended users;

(e) the performance characteristics of the device;

(g) any residual risks, contra-indications and any undesirable side-effects […];

(z) a notice […] that any serious incident […] should be reported to the manufacturer and the competent authority […].

Neither the Instructions for Use nor the substance of the information they must contain is provided. This is a significant non-conformity under Article 10 MDR.

Finally, the website and application content is not available in the official languages of all Member States in which the device can be downloaded, contrary to Article 10.11 MDR and the European Commission guidance “MDR: Language Requirements for Manufacturers” (Rev. 1, March 2024).

2. No Unique Device Identifier and no EUDAMED registration

Article 10.7 MDR requires manufacturers to comply with the UDI obligations referred to in Article 27 and the registration obligations referred to in Articles 29 and 31. The Unique Device Identifier is the code that allows a device to be identified unambiguously and traced on the market.

“AI Dermatologist” has no UDI and is not registered in the European Database on Medical Devices (EUDAMED). Nor is IAC Search and Media Europe, Ltd. registered there as the manufacturer or operator of the device. This is a significant non-conformity under Article 10 MDR.

3. No conformity assessment, and a misleading CE marking

Under Article 52 MDR, a Class III device that is not custom-made or investigational is subject to a conformity assessment involving a Notified Body, as specified in Annex IX, or alternatively in Annex X together with Annex XI. There is no evidence that “AI Dermatologist” has undergone any such assessment.

The application and website nevertheless display a CE marking. Article 10.6 MDR permits a manufacturer to draw up the EU declaration of conformity and affix the CE marking only once the applicable conformity assessment has demonstrated conformity, and Article 20 MDR provides:

Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 52. The identification number shall also be indicated in any promotional material which mentions that a device fulfils the requirements for CE marking.

The CE marking shown for “AI Dermatologist” is not followed by any Notified Body identification number. It appears beside the words “quality management system”, certified to ISO 13485, and the name of the certification company “LL-C (Certification)”. LL-C is a certification body for the ISO 13485 quality-management standard; it is not a Notified Body, and it cannot carry out the conformity assessment required by Article 52. For an Irish manufacturer one would expect the identification number of an Irish Notified Body (for example, NB 0050). Presenting the CE marking alongside the name of an ISO 13485 certifier, with no Notified Body number, creates the misleading impression that the device is validly certified. This irregularity is of a potentially fraudulent character and warrants investigation.

IV. Powers of the competent authority

Article 93.1 MDR requires competent authorities to carry out appropriate checks on the conformity and performance characteristics of devices, which may include reviewing documentation and conducting physical or laboratory testing on sufficient samples.

Article 94 MDR requires the competent authority, where it has reason to believe that a device may present an unacceptable risk to the health or safety of patients, users or other persons, or otherwise fails to comply with the Regulation, to carry out an evaluation of the device covering all the relevant requirements.

Article 95.1 MDR requires the competent authority, where such an evaluation establishes an unacceptable risk, to require the economic operators concerned to take all appropriate and duly justified corrective action without delay, in a manner proportionate to the risk, including restricting the availability of the device, withdrawing it from the market, or recalling it.

V. Relief sought

On the basis of the foregoing, MD Watchdog respectfully requests that the Health Products Regulatory Authority:

admit and process this report concerning the non-conformity of the medical device “AI Dermatologist”;
require the manufacturer or operator to remedy the non-conformities identified and to bring the device into full conformity with the MDR within a reasonable period;
order the withdrawal of “AI Dermatologist” from the market and the precautionary suspension of its availability through ai-derm.com, the Apple App Store and Google Play, and take all measures necessary to give effect to that order; and
impose such sanctions as may be appropriate under the applicable provisions.

Filed with the Health Products Regulatory Authority on 15 October 2025.

MD Watchdog

Regulatory Affairs