German Row Over Classification Of Telemonitoring Software Looks Set To Rumble On

Potential implications for telemonitoring software developers across the EU

When does an app qualify as a medical device and when does it not? A German court case appears to have wider-reaching implications for medtech than might first appear.

court house

Dermanostic, a German company based in Düsseldorf, is facing an ongoing legal challenge over the risk classification of its teledermatology software platform from competitor company, Online Doctor 24 but has so far been successful in defending its case.

Dermanostic has classified its product as a low-risk class I device in the context of the Medical Device Regulation. But Online Doctor contends that it should be in one...

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