The clinical evaluation of a medical device is updated throughout the lifecycle of a medical device with clinical data from Post-Market Surveillance (PMS) activities including Post-Market Clinical Follow-up (PMCF). Clinical evidence is needed to conduct a proper determination of the Benefit-Risk profile under normal conditions of the intended use of the device and to demonstrate acceptability of that profile based on current knowledge/state-of-the-art in the medical device field concerned.

Medical devices including Software as medical devices (SaMD) are also used in combination with a medicinal product leading to more innovative and complex products. Monitoring the safety and performance of medical device constituents is also important to ensure patient safety and minimize the risks associated with the use of medical devices.

This virtual workshop will provide relevant information to set up a PMS system, to know its challenges and opportunities, and to show the interdependencies between PMS, risk analysis, and clinical evaluation to continuously evaluate the safety and performance of a medical device and confirm the acceptability of the benefit-risk profile when used as a stand-alone device or as a constituent part of a drug-device combination product.

It will offer the experience from notified bodies, regulatory authorities and industry experts.