A case study will be followed from the extraction of the Post-Market Clinical Follow-up (PMCF) needs from the clinical evaluation report (CER), through the execution of those identified PMCF activities to the use of the PMCF data in updated risk management activities.
The session will take the form of a panel discussion, with the speakers giving some introductory remarks on key issues, then moving into an open Q&A.
In this panel discussion, a team of industry and Notified Body-seasoned consultants will follow the path of end-to-end PMCF activities through a case study. Join us on the journey with a practical example from 1) identifying /gaps in the clinical evidence of a device by means of the clinical evaluation report (CER), to 2) Post-Market Clinical Follow-up (PMCF) study design, conduct, and data analysis, through to 3) risk management updates. In this panel style discussion, you will be able to ask the team questions based on the practical knowledge shared and leverage the process presented with your own products.
Learning Objectives:
1. Key considerations in defining PMCF needs from the Clinical Evaluation and when to leverage PMCF data to address residual risks
2. Considerations for successful execution of PMCF activities
3. Justify the study design and sources of evidence used for the specific methods of the PMCF activity
4. How to set-up Risk Acceptability criteria to be relevant for both pre-market and post-market risk management
5. How to address “expected life” appropriately in PMCF activities and how to follow-up on this data if collected
6. Discuss the challenges of handling misuse and off-label use information when received