Description

The Postmarket Surveillance Plan Template is a vital document outlined in Annex III of the European Union Medical Device Regulation (EU MDR). This template provides a structured framework for medical device manufacturers to systematically monitor and evaluate the performance and safety of their devices after they have been placed on the market. It includes procedures for collecting, analyzing, and reporting data on adverse events, complaints, and other postmarket surveillance activities. By using the Postmarket Surveillance Plan Template, manufacturers can demonstrate compliance with regulatory requirements and ensure ongoing vigilance over the safety and performance of their devices. Compliance with Annex III of the EU MDR and adherence to the Postmarket Surveillance Plan Template help to identify and mitigate any potential risks associated with medical devices, thereby safeguarding patient safety and public health.