Instructions for Use (API)

Version	2.0
Date of issue	May 2026
Replaces version/revision	1.0
Product	SkinScreener API
Product version	1.1

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Please read the instructions for use carefully, especially the section entitled "Warnings."

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The application allows you to perform a skin lesion risk assessment for visual signs of premalignancy and malignancy quickly and easily. The artificial intelligence has been trained by appropriate images and compares the photographed lesion with an existing dataset of images to perform a risk assessment of your lesion. In case of a medium or high risk assessment, you will receive a recommendation to visit the dermatologist earlier for a lesion check-up to avoid further progress of the scanned suspicious lesion. In the case of a low risk assessment, the skin lesion should be observed regularly and scanned again, at least once a month. Nevertheless, the dermatologist should be visited for regular examinations within the prescribed screening intervals.

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The algorithm is trained to analyse images of skin lesions without additional magnifying tools and/or attachments (i.e. dermatoscope), taken frontally at a distance of 10 to 15 cm. It is important to ensure, that the lightning is even and that the image is of sufficient quality (i.e. blurriness).

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The SkinScreener application is not intended to replace conventional methods of examining and assessing skin cancer risk, does not provide a diagnosis, and does not replace a visit to a doctor. If you have any further questions about using the application, please contact support@medaia.atlassian.net

1 Intended use

The SkinScreener API is an interface intended to provide an AI based risk assessment (low, medium or high) for potential visual (pre-)malignant signs in images of skin lesions. The SkinScreener API cannot replace a dermatological examination, does not provide a diagnosis and cannot be a substitute for visiting a healthcare professional.

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2 Intended user group

The intended user is over 18 years old and does not need any previous knowledge or training. Basic knowledge of using an Android or iOS mobile device is an advantage.
Special language skills are not required as the application is available in the language of the target country/target market.
A skin lesion scan on the skin can basically be performed on all body parts, except for the excluded body parts described in the "Warnings/Exclusions" chapter.
Gender, age (18 years or older), or physical characteristics such as weight or height have no influence on the analysis.
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3 Indications

The user is over 18 years old.
The user is capable to process and understand simple visual instructions/information.
The lesion is located on skin of Fitzpatrick skin type I to IV.
The image displays a skin lesion on human skin (except lesions described in contraindications Nr. 3 - 11).
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4 Contraindications and limited use

The user is under 18 years old.
The lesion is located on skin of Fitzpatrick skin type V or VI.
The skin is sunburnt.
The lesion has been previously traumatized (excised/biopsied).
The skin surrounding the lesion is not intact (open sores, ulcers, bleeding).
The lesion is located on anatomical structures (i.e. eye, eyelid, mouth, nipples, genitals, nails, umbilicus).
The lesion is very close to visible scars or tattoo, or areas partly or fully covered with opaque or glittering substances like makeup, skin cream or sun cream.
The lesion is surrounded or covered by hair.
The lesion is on mucosal surfaces like on lips, in the mouth or penis/vagina.
The lesion is not located on human skin.
The lesion is located in a skin fold (i.e. ear, umbilicus).
Scanning lesions close to the eyes may cause temporary flash blindness caused by the camera light and should therefore be considered.
Individuals must not scan or be scanned when performing actions where this could cause harm (e.g. driving a car).
The SkinScreener API should not be used by people who may have difficulty recognizing a lesion to be assessed due to visual impairment, who have difficulty understanding the text or medical matters due to a lack of mental capacity, or who lack the technical understanding to operate a mobile device.
The SkinScreener API does not replace a regular consultation with a dermatologist.
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5 Interpretation of results

Skinscreener provides a risk assessment in 3 easy-to-understand categories. The categories and their respective meanings are listed below.

Assessment	What does this mean?	What should be done next?
Assessment LOW RISK (green)	What does this mean? Our clinically proven algorithm has not detected any abnormal skin changes in the examined area. The assessment was not performed by a physician and does not replace a medical examination. It is a risk assessment based solely on artificial intelligence and does not constitute a diagnosis. Our artificial intelligence is constantly being improved. Nevertheless, there is a possibility that the risk assessment of the skin change may be incorrect due to various circumstances. SkinScreener can make an important contribution to preventive care, but it does not replace regular examinations by your doctor; it can only complement them.	What should be done next? Check this lesion and your entire skin from time to time; it is important that you see your dermatologist regularly for a medical examination. Ask your dermatologist how often you should come in for an examination. If you are unsure about this risk assessment or if the skin change changes, contact your dermatologist immediately.
Assessment MEDIUM RISK (yellow)	What does this mean? Our clinically proven algorithm has assessed this skin change as abnormal. Irregular patterns, varying coloration, asymmetry, diffuse borders, enlarged diameter, and increased keratinization can be characteristics of abnormal skin changes. The assessment was not performed by a physician and does not replace a medical examination. This is a risk assessment based solely on artificial intelligence and does not constitute a diagnosis. Our artificial intelligence is constantly being improved. Nevertheless, there is a possibility that, due to various circumstances, the risk assessment of the skin lesion may not be correct. SkinScreener can make an important contribution to preventive care, but it cannot replace regular examinations by your doctor; it can only complement them.	What should be done next? The skin change must be examined more closely by a dermatologist. Your dermatologist must determine the check-up intervals and the affected skin areas. Check this lesion and your entire skin from time to time.
Assessment HIGH RISK (red)	What does this mean? Our clinically proven algorithm has rated this skin change as very conspicuous and identified various possible visual signs of skin cancer. For example, irregular patterns, different coloring, asymmetry, diffuse edges, enlarged diameter, and keratinization can indicate malignant skin changes. The assessment was not performed by a doctor and does not replace a medical examination. This is a risk assessment based solely on artificial intelligence and does not constitute a diagnosis. Our artificial intelligence is constantly being improved. Nevertheless, there is a possibility that the risk assessment of the skin change may be incorrect due to various circumstances. SkinScreener can make an important contribution to preventive care, but it does not replace regular examinations by your doctor; it can only complement them in a meaningful way.	What should be done next? The skin change must be examined by a dermatologist immediately. The dermatologist must also determine the further treatment, the check-up intervals, and the affected skin areas. Check this lesion and your entire skin from time to time.
Assessment No risk assessment possible	What does this mean? Lesions next to anatomical structures are sometimes difficult to detect. Even if an image is blurred or no lesion can be detected, no assessment is possible. To ensure the quality and validity of our assessments, we have excluded some anatomical regions or blurred images from the risk assessment.	What should be done next? Ask your dermatologist to evaluate this lesion.

6 Warnings/Exclusions

To ensure your personal safety and correct use, you should thoroughly familiarize yourself with the following warnings and the entire contents of this brochure before using the application. Contact your doctor or dermatologist if you notice any unexpected events or occurrences with the service. Using a mobile application may distract you in situations where full concentration is required. Be aware of your surroundings while using the third-party application.
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	The SkinScreener service does not replace a visit to your doctor! The SkinScreener service is a registered CE Class IIa medical device and is intended to assist in the risk assessment of skin cancer. SkinScreener is intended to supplement standard skin cancer screening and regular dermatological examinations, but it does not provide a diagnosis or replace regular consultations with a dermatologist.
	Do not use SkinScreener while driving, during physical activity, or in places where the use of mobile devices is prohibited! The application can generally be used anywhere where the use of a mobile device is permitted. The application must not be used in places where the use of mobile devices is prohibited. These places include, but are not limited to, certain areas in hospitals, on airplanes, in cars while driving, and anywhere else where the use of smartphones is prohibited or not recommended.
	Do not use the application if the camera/flashlight is not working! If the camera or flash of your mobile device is not working properly (broken, scratched, etc.) or if the mobile device becomes noticeably too hot, stop using the application.
	Do not use the service in the following cases: The lesion is on skin of Fitzpatrick skin type V (dark brown) or VI (darkest brown); The lesion has low visual contrast with the surrounding skin; The lesion is surrounded or covered by hair. The skin is sunburnt. The lesion has been previously traumatized (excised/biopsied). The skin around the lesion is not intact (open sores, ulcers, bleeding). The lesion is located on anatomical structures (i.e. eye lid, mouth, nipples, genitals, nails, umbilicus). The lesion is very close proximity to visible scars or tattoos or areas partly or fully covered with opaque or glittering substances such as makeup, skin cream, sun cream, or similar. The lesion is located on mucosal surfaces like on the lips, in the mouth, or in the genital region. The lesion is located in a skin fold (i.e. ear, umbilicus). The lesion is not located on human skin. The skin change is less than 4 weeks old;

Any serious incident should be reported to the manufacturer and the competent authority. An incident can be reported by email: support@medaia.atlassian.net or by post: medaia GmbH, Am Eisernen Tor 5, 8010 Graz, Austria.

A list of the competent authorities can be found at the following link: https://ec.europa.eu/health/document/download/c28e965a-3b7c-4a5b-a6ee-d1724d06f20d_en?filename=md_contact_points_of_national_authorities.pdf

7 Troubleshooting

Solutions to common problems can be found below. If you still need help with the application, please contact support@medaia.atlassian.net .

Problem	Solution
Problem The third-party application crashes during the evaluation process or does not function properly.	Solution Report the issue to our customer service team: support@medaia.atlassian.net
Problem The skin change is in a spot that is difficult to photograph.	Solution Ask someone else to assist you in photographing this lesion.
Problem The same skin lesion is classified differently when evaluated multiple times.	Solution Take a picture of the skin change under constant lighting conditions from a distance of 10 to 15 cm, as specified in the intended use. Larger (>15 cm) or smaller (<10 cm) distances reduce the reliability of the risk assessment. If there are different risk assessments within the intended distance, the most serious one shall be considered valid. In doubt, you should in any case consult a medical specialist.

8 Description of symbols

	Warnings: Text marked with a warning symbol must be read before using the device.
	Manufacturer: The device is manufactured by the manufacturer whose name and address are indicated next to the symbol. Indicates the manufacturer of the medical device in accordance with the Medical Devices Regulation 2017/745.
	CE Mark: The device complies with the Medical Devices Regulation 2017/745.
	Consult electronic instructions for use: Indicates that the user must consult the electronic instructions for use.

9 Privacy policy

In order to use the SkinScreener API service, medaia GmbH must collect data from you. We attach great importance to the privacy of our customers. For more information about the data we collect and how we process it, please visit www.skinscreener.com/legal-pages/API/privacy-policy

10 General Terms and Conditions

Before you can use the service, you must agree to the terms and conditions:www.skinscreener.com/legal-pages/API/terms-and-conditions .

11 CE Marking and Product Availability

The SkinScreener API is intended for integration into third-party applications and is CE marked as a Class IIa medical device in accordance with the Medical Device Regulation MDR 2017/745.

The instructions for use are available in the languages of the respective countries in which the product is marketed. The SkinScreener API is available in the following countries:

Austria
Germany
Ireland
United Kingdom
Portugal

All previous versions were standalone software and mobile applications for Android and iOS smartphones. This version is the first API in this category of our products.

Related and previous products

Product	Product version	Available platform	Status
Product SkinScreener	Product version 3	Available platform iOS and Android	Status Current
Product SkinScreener	Product version 2	Available platform iOS and Android	Status End of life
Product SkinScreener	Product version 1	Available platform iOS and Android	Status End of life

12 Product and manufacturer information

Product	Software version	Basic UDI-DI	UDI-DI
SkinScreener API	v1.1	912011561SKSC_APIW9	9120115610121

Contact us:

	medaia GmbH Am Eisernen Tor 5, 8010 Graz Austria Web: https://skinscreener.com Email: support@medaia.atlassian.net