MDR: What is Considered Sufficient Clinical Evidence?

Together with the introduction of Medical Device Regulation (MDR) 2017/745 clinical data become epicenter of many questions and even bigger need for medical device manufacturers. MDR expects from medical device manufacturers to develop and show sufficient data to demonstrate compliance with GSPR in rationalized and planned manner.

​How do we deal with these challenges? How those challenges affect our CER and PMCF plans? What is Considered Sufficient Clinical Evidence?



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