White paper: How to conduct medical device PMCF studies

White paper: how to conduct a medical device PMCF study

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The EU Medical Devices Regulation (MDR (EU) 2017/745) places greater emphasis on Post-Market Clinical Follow-up (PMCF) studies. Manufacturers are expected to perform more PMCF studies throughout the device lifecycle to maintain compliance with the regulation. With the MDR deadline approaching, device companies need to understand how to conduct a meaningful and ISO 14155-compliant PMCF study.

However, PMCF studies are more than a regulatory imperative; they are a critical component of post-market risk management to ensure the safety and efficacy of your product. In this white paper, two members of Emergo’s CRO in Germany examine PMCF requirements in the MDR and explain how to conduct a compliant medical device PMCF study. You will learn:

  • objective of PMCF studies,
  • PMCF planning according to the MDR,
  • key terms and definitions,
  • when PMCF studies are required,
  • and more.

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