Clinical data and post-market compliance under the MDR

Europe's new Medical Devices Regulation (MDR) emphasizes a life-cycle approach to medical device risk management. To support this approach, the MDR introduces complex post-market requirements for monitoring the safety and effectiveness of devices sold in the European market. Under the MDR, device companies must gain and maintain high-quality post-market clinical data and perform more post-market clinical follow-up (PMCF) studies to satisfy the demands of Notified Bodies and to maintain their CE certificates.

As the MDR deadline approaches, device manufacturers should carefully assess their current compliance with PMS and PMCF requirements to ensure a smooth transition. In this free webinar, we will discuss how to perform a gap analysis of your available clinical data as well as your PMS and PMCF plans and how to address discrepancies. 

In this one-hour webinar, you will learn:

  • an introduction to gap analyses
  • how to remedy discrepancies
  • when, where, and how to perform a PMCF study
  • cost-effective transfer mechanisms for Class IIa-III, up-classed, and legacy devices
  • how to plan and budget post-market activities year to year

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 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.

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.