Post-Market Clinical Follow Up Plan
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Use this Post-Market Clinical Follow-Up (PMCF) Plan template to systematically outline your planned activities for ongoing clinical data collection and safety monitoring of your medical device after it enters the market. Completing this document is essential for demonstrating continued device safety, performance, and benefit-risk acceptability, and should be filled out prior to or upon market launch, with updates as new post-market data or risks emerge. This template ensures you meet EU MDR requirements for proactive post-market surveillance and provides a structured approach for regulatory compliance and technical documentation.