Post-Market Surveillance Report
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Use this Post-Market Surveillance Report template to systematically collect, analyze, and summarize safety and performance data for your medical device after it has been placed on the market. Completing this report is essential every two years (or as requested by a notified body) to document vigilance data, complaints, incidents, and trend analyses, ensuring ongoing regulatory compliance and proactively identifying risks or needed improvements to your device. This template helps you fulfill EU MDR Article 84 and related requirements by providing structured evidence of your device’s post-market safety and performance.