Description: Manufacturers of medical devices are required to perform a benefit-risk determination of their products. Specifically, the MDR requests a benefit-risk assessment in several processes such as risk management, post market surveillance / post market clinical follow-up and finally the clinical evaluation. Sole statements such as “the benefit-risk ratio is positive” are generally no longer accepted by Notified Bodies. Hence, questions arise regarding how to substantiate the benefit-risk determination and where this evaluation should take place. Further, one may question if different processes should consider different aspects of benefits and risks?
In this lecture we will discuss the interaction between the clinical evaluation and the risk management in terms of benefit-risk determination, and how to combine the requirements of ISO 14971:2019 and MDR. What can we learn from the FDA concerning the benefit-risk determination? How can one quantify the benefit-risk ratio and does it even make sense to do so? After this lecture you will be up to date on the current state-of the-art of benefit-risk assessment, be able to prepare a solid benefit-risk evaluation and to defend your strategy for the benefit-risk determination.
Learning Objectives:
Upon completion of this lecture, participants will be able to understand the requirements of the benefit-risk assessment.
Upon completion of this lecture, participants will be able to know how different process interact in terms of benefit-risk determination.
Upon completion of this lecture, participants will be able to build up a founded and straightforward argumentation for the benefit-risk determination.
