POST-MARKET SURVEILLANCE

Chapter VII of the EU MDR focuses on post-market surveillance, vigilance, and market surveillance. Specifically, Article 83 of the EU MDR outlines the PMS System requirements. At a high level, manufacturers are required to "plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device."

The PMS System is required to actively and systematically record and review data to analyze the safety, performance, and quality of the device throughout its lifetime.

The gathered data should be used to update:

• the benefit-risk profile and improve risk management,
• the design and manufacturing information,
• the instructions for use and labeling, 
• the clinical evaluation, 

and identify

• the need for corrective and/or preventive actions,
• options to improve usability, performance, and/or safety of the device,

and, when relevant,

• to contribute to the post-market surveillance of other devices, and 
• to detect and report trends under Article 88 of the EU MDR

The PMS System is part of the technical documentation of the device. Safety and performance benchmarks may be identified in the PMS Plan or CER for the device under evaluation and its similar devices or competitors in the scope of review.

The PMSR and PSUR are authored in an identical manner and made available to the Notified Body to ensure compliance with the EU MDR. These documents include the results of the information outlined in the PMS Plan and updated on a pre-defined cadence (as described in the chart below).PSURs for Implantable and Class III devices and above must be uploaded to EUDAMED. The PSUR will not be publicly visible to all EUDAMED users.
As per the EU MDR, the primary goals of the PSUR are to highlight:

• the conclusions of the benefit-risk determination
• the main findings of the PMCF
• and the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.

Annexes can be added to the PSUR to meet the reporting requirements of other regions (such as Canada or Australia) rather than creating additional reports for those regions.