Post-Market Clinical Follow-Up Plan
Define the clinical follow-up activities you will carry out after a medical device reaches the market. This editable Post-Market Clinical Follow-Up (PMCF) Plan helps your team document objectives, methods, data sources, responsibilities and timelines, and connect the planned work to clinical evaluation and post-market surveillance (PMS).
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What you receive
An editable Microsoft Word PMCF Plan document supplied as a digital download. Review the document previews above to assess its structure before purchasing.
What the plan helps you document
The clinical questions and objectives to address after market release.
Methods, sources of clinical information and planned follow-up activities.
Responsibilities, timelines and how findings will be reviewed.
How results will inform the ongoing clinical evaluation and PMS plan.
When to choose this document
Choose the PMCF Plan when you need to define future clinical follow-up work. For completed activities and their findings, use the separately sold PMCF Evaluation Report. The plan describes what you intend to do; the evaluation report documents what the activities found and what the evidence means.
Regulatory context and implementation
The document supports PMCF planning under Regulation (EU) 2017/745 (EU MDR), including Annex XIV, Part B. Adapt it to your device, intended purpose, clinical evidence needs and working practices.
Connect the clinical evidence workflow
PMCF Evaluation Report: evaluate findings from the activities defined in your plan.
Clinical Evaluation Procedure: carry new clinical evidence into the ongoing 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 Plan is $49. Choose it when planning 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.
