Medical Device Manufacturers plan, establish, document, implement, maintain and update a Post-Market Surveillance System for each Medical Device in proportional to the risk class of the Medical Device and in accordance with the device type. This system should also be included in the Quality Management System.
Post-market surveillance (PMS) is a collection of processes and activities used to monitor the safety and performance of a Medical Device.
These activities are designed to collect information about device usage in order to quickly identify device design and/or usability issues and accurately characterize real-world device behavior and clinical outcomes. The requirement for PMS arises immediately after the commercialization of the Medical Device.
With MDR, many radical changes have been made in PMS processes, which have been based on MDD until now. In our opinion, the most important returns of MDR have been about PMS. With the new approach, critical reports to be made by Medical Device Manufacturers in PMS Processes are also included.