Post-Market Clinical Follow-up (PMCF) as part of Post-Market Surveillance is not a new requirement under the MDR. But requirements on how and when to do PMCF and on how to document these activities have been enforced. Each device (or device family) needs a specific PMCF Plan and results of PMCF activities are summarized in a PMCF Evaluation Report.
These documents are subjects to predefined review cycles and depend on several other input documents. The collection of clinical data is often time-consuming and expensive. The PMCF Plan aims to organise well-considered PMCF activities to generate the missing data. To be able to work on your PMCF Plans, you need to know general and specific methods for PMCF, the input documents and the trigger for PMCF. The results presented in the PMCF Evaluation Report will also affect several other parts of the Technical Documentation.
This course will give you profound insights into the regulatory requirements for PMCF, best practice advice on how to prepare PMCF Plans and Reports, as well as insights in common pitfalls and tips on how to prevent them.