Post-Market Clinical Follow-Up Evaluation Report
Turn completed post-market clinical follow-up (PMCF) activities into a structured evaluation of what the new clinical evidence means for your medical device. This editable PMCF Evaluation Report document guides your team through methods, populations, findings, deviations, conclusions and follow-up actions.
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What you receive
An editable Microsoft Word PMCF Evaluation Report document supplied as a digital download. Review the document previews above to assess its structure before purchasing.
What the report helps you document
The device, reporting period and PMCF activities evaluated.
Methods and populations, findings and deviations from the planned work.
What the findings mean for known and emerging risks and clinical performance.
Conclusions and proposed actions to feed back into clinical evaluation, risk management and PMS.
When to choose this document
Choose this report when you need to evaluate findings from completed PMCF activities. To define the objectives, methods and timing before collecting evidence, use the separately sold Post-Market Clinical Follow-Up Plan. The plan describes the intended work; this report records and evaluates its results.
Regulatory context and implementation
The document supports PMCF evaluation reporting under Regulation (EU) 2017/745 (EU MDR), including Annex XIV, Part B. PMCF feeds the continuing clinical evaluation. Adapt the report to your device, activities, evidence and reporting period.
Connect the clinical evidence workflow
Post-Market Clinical Follow-Up Plan: define the clinical follow-up work that the report evaluates.
Clinical Evaluation Procedure: incorporate the findings into the ongoing clinical evaluation.
Post Market Surveillance Procedure: connect clinical findings with broader post-market feedback and follow-up decisions.
These related products are sold separately.
Individual document or bundle?
This PMCF Evaluation Report is $49. Choose it when reporting is the document you need. It is also included in the Clinical Evaluation Procedure Bundle, which combines clinical evaluation, PMCF planning and reporting, PMS and clinical investigation. Compare the included products before purchasing to avoid duplicate purchases.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read PMCF Plan vs PMCF Evaluation Report: What Each Document Does for workflow guidance, a checklist and common mistakes.
