Procedure for EU MDR Clinical Investigation

Looking for a process flow (map) of how Clinical Investigation, Risk Management, PMS, and Clinical Evaluation meet.

 

Ooh... that's a toughie. I put together the attached based on my understanding. There's not full agreement, though, that a PMCF Plan is required (although the MDR seems to calls it out). So take this with a big grain of salt. (And I would welcome ANY feedback on this!!)

It doesn't fully address the risk management part, though. I would say that risk management permeates the whole flow. Your risks should drive the focus of your postmarket activities. Certainly any adverse events or complaints need to feed into your risk assessments and that could drive the need for additional studies. The whole focus on postmarket activities is to ensure ongoing safety (and efficacy).