Post-Market Clinical Follow-up (PMCF) Plan

Download a free template (MS Word)

Manufacturers of medical devices selling products in the EU must perform post-market clinical follow-up (PMCF) activities as part of the post-market surveillance (PMS) system to ensure the safety and efficacy of their medical devices. The PCMF Plan helps manufacturers to specify the procedures and methods for proactive collection of post-market clinical data, evaluation of data, and identification of potential issues with medical devices.

With this free PMCF Plan template, manufacturers can make sure they are prepared to:

  • Identify previously unknown side effects, and monitor identified side effects and contraindications
  • Pinpoint and analyze emergent risks based on factual evidence
  • Ensure the ongoing acceptability of the benefit-risk ratio
  • Identify potential systematic misuse or off-label use of the device
Post-market Clinical Follow-up (PMCF) Plan

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