Quick question on constructing the technical documentation

Thank you for participating in the webinar and for your follow-up question. MDR Article 83(1) states that “for each device,” the manufacturer shall plan, establish, document, implement, maintain, and update a post-market surveillance system, proportionate to the risk class and appropriate for the type of device.                                                                                             

In addition, MDCG 2025-10, “Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices”, provides an explicit clarification. A PMS Plan may cover either a single device or a group of devices - devices with the same manufacturing process, design, and intended purpose, or devices within the same device family. In such cases, the PMS Plan should clearly state which devices are included within its scope.                                                                                                                                            

Therefore, when I referred to the PMS Plan as being device-specific, the intention was that it cannot be a purely generic QMS-level PMS procedure. The PMS Plan must define the device or group of devices covered, the PMS activities, data sources, methods, indicators, thresholds, frequency of monitoring, and rationale in a manner that is appropriate to the specific device or defined device family.