Medical device

We are solely responsible for declaring the compliance of the dermanostic app in accordance with the requirements of MDR 2017/745.

The dermanostic app is a risk class I medical device in accordance with Rule 11 (11.5), complies with the relevant provisions of MDR 2017/745 and is CE marked.

Intended purpose

The "dermanostic" app is a medical device software and serves to improve patient management in the field of teledermatological examination of potentially pathological skin areas. The "dermanostic" app supports communication between patients and medical specialists by recording, storing, displaying and transmitting digital images of the main areas affected, recording a medical history and conversing with specialists (chat function).

The "dermanostic" app does not provide any interpretative information and does not interfere with diagnostic or therapeutic decisions made by medical professionals. A diagnostic or therapeutic decision is made exclusively by medical professionals within the framework of the assessment of the unaltered image material transmitted by the "dermanostic" app. If the image quality is insufficient, additional images can be submitted. Alternatively, medical specialists can initiate an on-site examination.