PMCF Plan vs PMCF Evaluation Report: What Each Document Does
A post-market clinical follow-up plan describes the clinical questions and activities to pursue after marketing. A PMCF evaluation report assesses the completed activities and their findings. Keeping these documents distinct makes it easier to compare what was intended with what actually happened and decide what should change next.
Plan around evidence gaps
Start with unresolved clinical questions, uncertainties and the conclusions of the current clinical evaluation. Choose methods that can answer those questions, identify data sources and explain why they are suitable. Assign responsibilities and a timetable for collection, analysis and reporting. Account for the limitations of each method before treating it as adequate for the objective.
Evaluate completed work against the plan
Describe the methods used, available data, relevant populations and departures from the planned activities. Assess findings alongside limitations such as incomplete follow-up or differences in how users were sampled. Explain the implications for clinical evaluation, benefit-risk conclusions, risk controls and the next PMCF cycle.
Practical checklist
State the clinical question.
Choose justified data sources and methods.
Assign owners and timeframes.
Record completion and departures from the plan.
Translate results into evidence and follow-up decisions.
Example
A planned survey may receive fewer responses than expected or mainly reach experienced users. The evaluation report should explain how that affects interpretation and whether additional activity is needed, rather than declare the objective complete solely because a survey was sent.
Common mistakes
Avoid using the same prospective wording in both documents. The plan describes intended work; the evaluation report needs actual methods, results, analysis and justified conclusions.
Choose the relevant A.P. Lyon documents
Use the PMCF plan document to define objectives, methods, sources, responsibilities and timelines.
Use the PMCF evaluation report document to assess completed follow-up findings and their implications for the device evidence.
Review the product page, document previews and any content list before choosing. Adapt the selected documents to your device, processes and applicable requirements; the organization must generate and review its own implementation evidence.
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