With OnlineDoctor 24 and Dermanostic, two providers of digital dermatology services have for some time been fighting a legal dispute over the correct risk classification under the MDR. After an earlier decision to the contrary, a new judgment has now been handed down in appeal proceedings:<\/p>\n
The Hanseatic Higher Regional Court ruled that Dermanostic’s dermatology app must be assigned to a higher class under the MDR. Until now, the dermatology app in question had been classified by the manufacturer in risk class I (MDR).<\/p>\n
In future, according to the ruling, Dermanostic must therefore have the product certified at least under class IIa (MDR). The court based its decision on the fact that, through an individualised medical history, the dermatology app supplies doctors with information that serves as a basis for diagnosis. The app collects data with a dynamic questionnaire which, depending on a user’s answers, displays or skips certain questions. The app therefore has a hand in deciding what information the doctor is presented with in the end.<\/p>\n
This meets the criteria for risk class IIa under rule 11 of chapter III of Annex VIII of the MDR, which reads:<\/p>\n
“Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, (…)”<\/p><\/blockquote>\n
According to the ruling, this is supported by wording in the intended purpose of the app as well as in other parts of the technical documentation.<\/p>\n
The service offered by OnlineDoctor 24, which is very similar in scope, is itself a class I medical device, although still under the MDD. It made use of the transitional arrangement, under which products approved under the MDD can remain on the market provided an agreement on implementing the MDR has been concluded with a notified body. Certification to class IIa (MDR) is currently being sought.<\/p>\n
Read more in the article on Apotheke Adhoc:<\/p>\n