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 gain verification of the clinical performance of your product and to 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 free 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 you learn:
- if and when to conduct a PMCF study;
- 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;
- and much more.
ABOUT THE PRESENTERS
Jaap Laufer, MD, PharmD is the Medical Director at Emergo by UL. Dr. Laufer has over 30 years of experience in the medical device and pharmaceutical industries. He previously held executive and senior regulatory positions at Pfizer, Abbott Laboratories, LipoMatrix, and other companies. His areas of expertise include a vast array of mostly implant, combination. and high-risk products; ISO and FDA QSR audits; and clinical study approvals, compliance and implementation. He holds a PharmD in Pharmacy from the University of Groningen and is an MD from the Medical School of the University of Nijmegen, both in The Netherlands. Dr. Laufer is a member of the Medical Devices Expert Group to the EU Commission and teaches at the University of Southern California.
Dietmar Falke, PhD heads the Clinical Research team at Emergo by UL. For more than 13 years, Dr. Falke has been involved in or responsible for conducting pharmaceutical and medical device clinical studies. He has wide experience in project management of clinical studies 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.