PMCF Workshop: how to collect valuable data and use it to your benefit?

Description: The European Medical Device Regulation (MDR) requires all manufacturers of medical devices marketed in Europe to continuously assess the safety and performance of their devices using the clinical evaluation process and the post market clinical follow-up (PMCF) process. Many manufacturers struggle with gathering sufficient clinical data and have started collecting patient-specific clinical data with PMCF surveys. However, the process does not stop with collecting all information. Most important is a proper analysis of the gathered PMCF data, defining and implementing actions and updating the clinical evaluation and related documents, hopefully to support that the device is safe and performs as intended.
This interactive workshop with examples and exercises will start with an outline of the clinical evaluation process. The interaction of the clinical evaluation with other documents, such as the risk management file, the instructions for use, the Summary of Safety and Clinical Performance (SSCP) will be covered. The linkage between the clinical evaluation process and the PMCF process, the need for sufficient clinical data and requirements for PMCF will be covered.
During the workshop, a PMCF survey will be used as an example to collect patient-specific data. With this example, it will be explained how to analyse and report PMCF data, including what to do with reported adverse events, off-label use and any other unexpected findings. Furthermore, efficient ways to update risk management and the clinical evaluation will be discussed. Also, the need and implementation of follow-up actions such as trend reporting, review and update of instructions for use and SSCP will be covered. Lastly, this process will be reviewed from a more strategic perspective in order to identify ways to streamline this process for similar devices.

08H00 – 08h30 Workshop Registration
08h30 – 10h00 The clinical evaluation process and PMCF requirements
10h00 – 10h30 Coffee Break
10h30 – 11h30 Design & implementation of PMCF surveys
11h30 – 12h00 How to analyse PMCF survey data?
12h00 – 13h00 Lunch
13h00 – 14h30 How to analyse and follow-up on PMCF data?
14h30 – 15h00 Coffee Break
15h00 – 15h30 Close the loop: update clinical evaluation and related documents
15h30 – 16h00 Conclusions