Regenold and Sträter Rechtsanwälte report on LinkedIn on a decision by the Higher Regional Court of Hamburg: the revised dermatology app dermanostic no longer falls under the distribution ban imposed on it.
Back in June, the court ruled that dermanostic may not distribute the app for the “asynchronous examination of skin conditions” without having it certified under class IIa (MDR). The manufacturer then narrowed the purpose of the app to improvements in patient management. In addition, a static questionnaire is now used for taking the medical history, which merely passes on the answers unchanged.
As a result of these adjustments, the court considers the product now sufficiently different from the version objected to, so that the distribution ban imposed is no longer applicable.
The question frequently discussed in the community, namely whether dermanostic is a medical device at all, was not addressed by the court. It referred to the classification by the manufacturer itself, which designates the app as a class I medical device under the MDR.