Handelsblatt reported in its digital health newsletter at the beginning of April: the online dermatology practice Dermanostic has received certification as a class IIa medical device.
Behind this formal recognition, however, lies a longer dispute with the competitor OnlineDoctor, which sued Dermanostic last year, alleging that it was not sufficiently certified. At the time in question, both providers were competing for a health insurer tender and offer a very similar service in the field of teledermatological initial assessment.
The courts ultimately confirmed the need for IIa certification for this type of application. While OnlineDoctor still offers its service under class I MDD based on the MDR transitional arrangement, Dermanostic has now overtaken its competitor, but stresses that this step had been planned anyway.
Read more about the differences between risk class I and IIa in our blog article MDR risk class I vs. IIa: differences for software medical devices