Post Market Clinical Follow Up Plan
Post Market Clinical Follow-up (PMCF) Plan. User friendly, detailed guidance, The post-market clinical follow-up (PMCF) is a continuous process that updates the clinical evaluation and is made part of the manufacturer’s post-market surveillance (PMS) plan.
- MS Word Format
- MDR 2017/745 Compliant
- ISO 13485:2016 Compliant
- Digital Content-Instant Download
Post Market Clinical Follow-Up (PMCF) PlanPost Market Clinical Follow-up (PMCF) Plan. User friendly, detailed guidance, MDR 2017/745 format. The purpose of the PMCF Plan is to guide users in complying with the requirements of the MDR with respect to the compilation of the PMCF plan.
Post Market Clinical Follow-Up (PMCF) Plan - OverviewThe Medical Device Regulation (EU) 2017/745 (MDR) considers the post-market clinical follow-up (PMCF) as a continuous process that updates the clinical evaluation and that shall be addressed in the manufacturer’s post-market surveillance (PMS) plan. The MDR reinforces the PMCF process by the manufacturer, devoting part B of Annex XIV to it and providing a set of requirements for developing a plan, necessary to implement PMCF.
Post Market Clinical Follow-Up (PMCF) Plan - ComplianceThe Post Market Clinical Follow-Up Plan (PMCF) is compliant with the requirements of MDR 2017/745 and EU Guidance.
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