Under EU-MDR, manufacturers are responsible for conducting post-market surveillance (PMS) activities to actively and systematically gather, record and analyze relevant data on the quality, per-formance and safety of a device throughout the entire device lifetime. Manufacturers must update their risk management system based on the information collected during post-market surveillance activities.
The PMS-System comprises various “sub-processes”, i.e. CAPA, PMCF and vigilance reporting. In addition, there is a close interrelation to the Clinical Evaluation and Risk-Management process.
The PMS activities should be conducted according to a documented PMS plan per Annex III 1.1 of EU MDR. The extent of PMS activities depends on several factors, such as the existing or new risks associated with the medical device, the chosen data sources or the expected quality of the available information on safety and performance.
Depending on the device risk classification, the system also must describe the relevant report output either being the PSUR referred to in Article 86 and the post-market surveillance report referred to in Article 85.
The participants will gain a structured overview of the PMS-System and its components to under-stand the requirements and interrelation to other documents and processes.