Description: The Post Market Clinical Follow-up (PMCF) involves the proactive collection and evaluation of clinical data from CE-marked medical devices. PMCFsurveys can provide a cost-effective and quick way of collecting and providing post-market safety and performance data to be used within MDRsubmissions as an additional data source. As per the MDCG-2020-6 guidance PMCF surveys fall into 2 categories of clinical data, Level 4 and Level 8.This session will focus on high-quality level 4 surveys and how they can be implemented to collect good clinical data manufacturers can use to certifytheir devices. To collect data successfully manufacturers must plan effectively, laying out clear endpoints and how they will be met. This session willaddress how to plan, design, implement and report on Level 4 high-quality PMCF surveys, especially delving into possible pitfalls device manufacturersface when setting up these surveys.
Learning Objectives:
Understand what makes a Level 4 PMCF survey “high-quality”
Be well equipped to know when Level 4 PMCF surveys are appropriate and when they should be used
Understand the steps/processes needed to properly implement a Level 4 PMCF survey to obtain high-quality PMCF data
