What is a PMCF plan and what does it include?

In its document MDCG 2020-7, the Medical Device Coordination Group (MDCG) presents the so-called “Post-market clinical follow-up (PMCF) Plan Template — A guide for manufacturers and notified bodies.” This is the official template for Europe, with the help of which the plan for post-marketing clinical follow-up is to be drawn up.

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Overview and aim of the document

The PMCF plan Is part of Monitoring according to the marketing package (English post-market surveillance, PMS) and is used to systematically and proactively collect and evaluate clinical data in order to:

• Safety and performance to confirm the product over its entire lifetime
• new side effects and risks to recognize
• Acceptability of benefit-risk ratio to check
• Possible Misapplications or Off-label applications to identify and evaluate.

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Design of the sample template

The document is divided into the following main sections:

• Section A: Manufacturer contact details
• Section B: Description and specification of the medical device
• Section C: Presentation of all PMCF activities (methods, timelines, goals, reasons, e.g. registers, PMCF studies, real world data, surveys)
• Section D: Reference to relevant delivery documents and technical documentation
• Section E: Evaluation of clinical data on comparable or similar products
• Section F: References to applicable specifications, standards, or policy documents
• Section G: Provide the estimated date for the PMCF evaluation report.

Documentation requirements and references

• The results of the PMCF activities are presented in a separate evaluation report (“PMCF Evaluation Report”) summarizes and is a mandatory part of technical documentation and regular clinical evaluation.
• The notified body may review both the preparation of the PMCF plan and implementation as part of the clinical evaluation process.

The template is always filled out in tabular form, must be adapted to specific products and provides many formulation examples and assistance to meet regulatory requirements. After carrying out the tasks set out in the PMCF plan, the PMCF report to write and submit it to the authorities or the notified body.

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MEDIACC supports you with creating and maintaining PMCF plans, dem documentation management, The clinical data analysis as well as Study planning and regulatory advice. Feel free to arrange a first non-binding appointment with us!

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Source: https://health.ec.europa.e u/system /files/2020 -09/md_mdcg_2020_7_guidance_pmcf_plan_template_en_0.pdf (remove spaces for link)