The introduction of the EU MDR brings greatly increased ongoing Post-Market Surveillance (PMS) expectations for both manufacturers and economic operators. Articles 83-86 and Annex III detail the requirements, but without defining the expectations to be fully compliant. It is often difficult for manufacturers to translate their existing PMS data and processes into the more rigorous framework of the EU MDR. Creating a pragmatic process that fulfils requirements whilst not becoming overly burdensome is critical to the ongoing success of the PMS system.
This session will address the practical aspects of setting up an effective PMS plan, considering the requirements and methods tailored appropriately to class and nature of the device. Selecting sources of data to set and monitor suitable indicators and threshold values will be addressed, as well as effective trend reporting and monitoring. The output of the PMS process is the PSUR (article 86) or post-market surveillance report (Article 85), which supports the ongoing risk/benefit assessment, and becomes an integral part of continued compliance to the MDR. Information is drawn together from many sources, including risk management, post market clinical follow-up (PMCF), vigilance, trend reporting and clinical evaluation. To implement a practical process to prepare these documents the inter-relationship between the relevant processes needs to be understood. We will address the practical execution of the PSUR process, considering timelines to gather data from relevant sources, and providing a meaningful output for both manufacturers and regulators. Potential challenges and pitfalls will be considered.
Demonstrate their understanding of the key concepts and requirements of PMS and its outputs.
Interpret the principles discussed and apply them practically within their organization to create pragmatic solutions to meet PMS/PSUR requirements.
Review their organization's current PMS processes to address this need and amend them to create pragmatic solutions to meet the requirements.