The Medical Devices Introductory Course 2020

Risk management

• The conclusions of the PMCF evaluation report shall be taken into account for risk management • If, through the PMCF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them, e.g. • Changes to labelling/instructions for use • Changes to manufacturing processes • Changes to the device design • Public health notifications (i.e. safety alerts, market withdrawals)

The Organisation for Professionals in Regulatory Affairs

Learning Outcomes Reminder:

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