Telemedicine software under scrutiny – German court classifies dermatology software as class IIa medical device under the MDR

Initially CE marked as a class I medical device following an EU declaration of conformity issued by its manufacturer, the app's classification was contested by a competitor. In a landmark decision the Regional Court Hamburg decided that the app has to be classified as a class IIa medical device requiring the involvement of a notified body to conduct the conformity assessment procedure.

The app in dispute is a telemedicine app which offers a digital skin-check allowing patients to submit skin condition images for diagnosis. The patient takes pictures of their skin alteration and submits them using the platform of the app. Additionally, the patient answers an anamnesis form. A dermatologist examines the pictures and, if necessary, asks for additional information or pictures. If they have gathered sufficient information, they make a diagnosis and provide it to the patient.

The court’s rationale

The court classified this app as a class IIa medical device under rule 11 of Annex VIII of the MDR. Accordingly, software “intended to provide information which is used to take decisions with diagnosis or therapeutic purposes” qualifies at least as class IIa medical device.

The court referred to the word “provide” which in their understanding also includes the mere transfer of information. It would not be necessary that information is generated by the app, e.g. that the software filters the pictures before it submits them to the doctor, to match the wording “provide”.

The court argues that the purpose of the MDR is to maintain a high standard of protection for human health. This purpose would not be fulfilled if software, like the one which was subject of the lawsuit, was not recognized as software which provides information and therefore would not be classified as a class IIa medical device. According to the Court the abstract risk for patients using telemedicine software is­­ ­­­­­too high to classify such software in a lower risk class than IIa.

Opposition against the IIa classification of telemedicine software

This judgment could significantly impact providers of telemedicine software, which would have to undergo a class IIa conformity assessment procedure involving a notified body. Nevertheless, there are also strong arguments to doubt the court's conclusions. In the previous instance the Regional Court of Hamburg decided to the contrary and ruled that a classification of the app as class I medical device was sufficient.

It is not only relevant that information is provided but who provides the information. Here the app only forwards the information, the provider however, is the patient. Critics point out that following the understanding of the Higher Regional Court every communication software that forwards diagnostic and therapeutic information would have to be classified as a class IIa medical device.

Furthermore, the rule 11 of Annex VIII of the MDR cannot be applied alone but must be interpreted in the light of Article 51 para. 1 MDR. Therefore, the risk for the patients should not be considered from an abstract point of view. Rather, a concrete risk-based benchmark must be applied. The mere transfer of the pictures does not lead to a higher risk of misdiagnosis per se. Especially, because the dermatologist can demand further pictures if the quality or information is not yet to their content. Human misinterpretation could not be prevented through conformity assessment procedures.

Is telemedicine software a medical device at all?

Beyond the debate over classification, one might even argue that the app (and comparable telemedicine software) would not qualify as medical device at all.

According to the definition of the MDR, a medical device must have a medical purpose, as opposed to a purely general purpose. It could be argued that a telemedicine software which only transfers information like a communication application only has such general purpose and therefore would not be classified as a medical device at all. German legal academics have criticized the Higher Regional Court for not addressing this issue at all.

Impact on practice and the market

The ruling has far-reaching consequences for the industry, potentially altering the regulatory landscape and affecting how telemedicine services are provided and managed. Providers of telemedicine software would have to conduct a lengthy and expensive class IIa MDR conformity assessment procedure following the decision. It remains to be seen whether other courts will follow the arguments of the Hanseatic Higher Regional Court Hamburg and decide in a similar way.