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

You may unsubscribe at any time.

For more information on what personal data we collect, why we need it, what we do with it, how long we keep it, and what your rights are, see this Privacy Notice.
Advisera   LinkedIn_logo Facebook_logo Twitter_logo Youtube_logo

Copyright © Advisera Expert Solutions Ltd