Post-Market Clinical Follow-Up Evaluation Report
The PMCF Evaluation Report document guides manufacturers in complying with the requirements of the MDR with respect to the compilation of the PMCF evaluation report. This product helps manufacturers present post market clinical data to notified bodies and competent authorities in an organized format.
MS Word Format
MDR 2017/745 aligned
EU Guidance aligned
Digital Content - Instant Download
The PMCF Evaluation Report document guides manufacturers in complying with the requirements of the MDR with respect to the compilation of the PMCF evaluation report. This product helps manufacturers present post market clinical data to notified bodies and competent authorities in an organized format.
Post Market Clinical Follow-Up (PMCF) Evaluation Report - Overview
The 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 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 PMCF plan and its evaluation report, necessary to its implementation.
Post Market Clinical Follow-Up (PMCF) Evaluation Report - Compliance
The PMCF Evaluation Report document supports implementation of MDR 2017/745
