PMCF data can only be used for regulatory purposes when the PMCF activity has been properly designed and is of high quality, with well-defined clinical endpoint(s), that collect data on the clinical safety and performance of the device in scope.
Key components in the development of high-quality PMCF activities are:
- Clear scope
- Appropriate design including research questions, objectives, endpoints
- Evaluation of potential sources of bias or study distortion
- Statistical justification, statistical analysis plan, acceptance criteria
- Data analysis plan and a plan for drawing appropriate conclusions
- Accessibility and responsiveness of appropriate target population
Are you working on your PMCF plan and you have questions? Or would you like to verify your thoughts with us? We offer our 360o PMCF strategy review for a fixed price of EUR2450 per product. We will review your PMCF plan, evaluate your set-up in line with your products CER and IFU, provide our feedback on any related documentation, e.g. protocol (synopsis), survey, registry plan etc.