The EU MDR has introduced enhanced requirements for clinical data and proactive PMCF. This presents a problem for most manufacturers since marketing surveys are insufficient to meet these requirements and clinical trials are too time-consuming and expensive. Retrospective PMCF chart review studies offer a unique alternative to both of these options by enabling the collection of clinically relevant outcomes in a timely manner and for a reasonable cost. This session will provide an overview of what is involved in conducting retrospective PMCF chart review studies as well as lessons learned based on experience submitting these as part of EU MDR submissions.
Learning Objectives:
Participants will gain an understanding of retrospective PMCF chart reviews studies and the advantages and disadvantages of them relative to marketing surveys and clinical investigations.
Participants will gain an understanding of what are important things to consider when conducting retrospective PMCF chart review studies.
