The Medical Devices Introductory Course 2020

Clinical Evaluation, Clinical Investigation & PMCF

Rachel Hattersley-Dykes

The Organisation for Professionals in Regulatory Affairs

Learning Outcomes To gain an understanding of:

What Clinical Evaluation is and why it is needed The main documents that pertain to Clinical Evaluation including the Clinical Evaluation Report (CER) What a Literature Review is and the principles of how it should be conducted The contents of a CER Clinical investigations – when are they needed, what are the key requirements for conducting them and what approval is needed to carry them out What Post-Market Clinical Follow-up (PMCF) is and what it is not Common reasons why PMCF may be performed Requirements for undertaking PMCF including the PMCF plan and what needs to be done as a result of conducting PMCF

The Organisation for Professionals in Regulatory Affairs