Clinical data and post-market compliance under the MDR

The EU Medical Devices Regulation (MDR 2017/745) emphasizes post-market clinical follow-up (PMCF) studies for collecting structured post-market data about your device. A PMCF study examines how your device performs when used as intended to verify the clinical performance of your product and collect safety information. Under the MDR, manufacturers are expected to perform more PMCF studies throughout the device lifecycle. Based on their opinion of your data supporting the safety and performance of the product, your Notified Body can require a PMCF study at any time, so it’s important to understand how to conduct a meaningful and ISO 14155-compliant PMCF study.

In this complimentary webinar, you’ll gain insights from Emergo’s medical device clinical research team on the role of PMCF studies in MDR compliance and what it takes to conduct a PMCF study that should be acceptable to all stakeholders. Here’s what you will learn:

  • If and when to conduct a PMCF study
  • Medical Device Coordination Group (MDCG) requirements
  • How PMCF studies can address the MDR data gap
  • The relationship between post-market surveillance, PMCF and risk management
  • PMCF pre-approval process
  • PMCF study structures and methodologies, including the place for retrospective studies
  • ISO 14155 and GCP requirements  



Dietmar Falke

Senior consultant, clinical research, Emergo by UL

Dietmar Falke, PhD heads the Clinical Research team at Emergo by UL. For more than 18 years, Dr. Falke has been involved in or responsible for conducting pharmaceutical and medical device clinical studies. He has wide experience in clinical study product management, from trial design to the generation of the final report, including submission to authorities and ethics committees. In addition, he has significant experience in the interpretation and presentation of study results. Dr. Falke holds a PhD in Microbiology from the Eberhards-Karls-University of Tübingen in Germany. Prior to entering clinical research, he spent several years as a post-doctoral fellow in the department of pharmacology at the University of North Carolina.

This webinar was recorded on June 30, 2022.