PMCF Justification Template

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This template furnishes a thorough justification for the exemption of a post-market clinical follow-up for the device, citing MEDDEV 2.12/2 Rev 2 guidelines. This document is essential for streamlining regulatory compliance efforts by providing a clear rationale based on the known medium to long-term safety and clinical performance of the device from previous usage. The justification emphasizes that appropriately framed Post-Market Surveillance (PMS) activities yield sufficient data to identify and mitigate risks associated with the device’s use.

This template is designed by highly experienced professionals for all medical device companies. Click below to get a preview of this template.