During this session, the participants will discuss a case study, which is an existing product with the goal to understand some of the principles related to SaMD determination and classification, considerations around preventive devices and mental diseases (vs physical conditions). Understanding the principles help participants make compliant regulatory decisions where there are no guidelines readily available. If any participants will have relevant experience, their particular challenges will also be discussed, as time permits.
Learning Objectives:
determine whether their software product is considered a medical device in the EU, even if the relevant guideline doesn't explicitly list it.
classify their SaMD product under the MDR, even if the relevant guideline doesn't explicitly list its classification.
forumlate regulatory strategy for some complex products incorporating emerging technologies, considering their intended use and clinical field.