From the idea to a standard-compliant mobile medical app – A field report
The qualification and classification of medical software and mobile medical apps are subject to strict and, above all, complex requirements of the Medical Devices Regulation.
On the basis of the MDCG guidelines, the lecture draws a distinction between definitions and then delves into the topic of medical device classification of software.
In addition to a theoretical part, different types of software and mobile medical apps will be discussed using examples from practice. Furthermore, experiences and approaches from current projects will be shared, which will also shed light on other MDR topics such as clinical evaluation and post-market surveillance activities.
Finally, the question of the continued existence of Class I software beyond the validity of the old Medical Device Directive will be answered. The roundtable will provide an overview of the new developments in the Medical Devices Directive with a focus on software and mobile medical applications.
Different assumptions and interpretations will be discussed, with the audience being guided step by step through the regulation.
Speaker: Miriam Schulze