Skip to main content
  • On-demand Webinar

Clinical Data and Post-Market Compliance Under the MDR

Gain insights from our 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.

Clinical data and post-market compliance under the MDR

Watch Now: 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.

Webinar date

June 30, 2022

Speaker

Dietmar Falke, Senior consultant, clinical research, Emergo by UL

 

This webinar will help you gain a better understanding of 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.

Learning objectives:
  • 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  
About the presenter:

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.

 

Attend an upcoming webinar

Ready to elevate your industry IQ with insights and news from experts? Register for one of our upcoming events.

View upcoming webinars
X

Get connected with our sales team

Thanks for your interest in our products and services. Let's collect some information so we can connect you with the right person.

Please wait…