Description

The PMS (Postmarket Surveillance) Report Template for Class I devices is a crucial document outlined in the European Union Medical Device Regulation (EU MDR). This template provides a structured framework for manufacturers of Class I medical devices to systematically collect, analyze, and report data on the performance and safety of their devices after they have been placed on the market. It includes procedures for documenting adverse events, complaints, and other postmarket surveillance activities, as well as the analysis of trends and patterns to identify potential risks or issues. By using the PMS Report Template, manufacturers can demonstrate compliance with regulatory requirements and ensure ongoing vigilance over the safety and performance of their Class I devices.