Periodic Safety Update Report
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Use this Periodic Safety Update Report (PSUR) template to systematically document and analyze the post-market safety, performance, and risk-benefit profile of your medical device, as required for EU MDR compliance. Complete this template at the specified intervals (annually or biennially, depending on device class) to summarize sales, incidents, corrective actions, complaints, literature review, and post-market clinical follow-up, ensuring proactive identification and management of safety concerns. This report is crucial for demonstrating ongoing device safety and performance to notified bodies and regulatory authorities.