EU MDR PMS Including PMCF and Vigilance

Learn more about EU Medical Device Regulation (MDR) requirements for post-market surveillance (PMS) and post-market clinical follow-up (PMCF).

THE CONTENT OF THIS WEBINAR IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

Watch now: EU MDR PMS including PMCF and vigilance

Learn practical information intended to empower manufacturers to create robust and compliant processes.

Webinar date

Sept. 26, 2023

Speaker

Dasun Abey, lead consultant, Quality and Regulatory Affairs, Emergo by UL

With the increased focus on device traceability under the Medical Device Regulation (MDR), post-market surveillance (PMS) and post-market clinical follow-up (PMCF) have become heavily scrutinized aspects of EU device submissions. In this webinar, the presenter will help attendees develop a greater understanding of the MDR requirements and notified body expectations related to PMS, PMCF and vigilance, as well as the latest guidance related to each topic.

About the presenter

Dasun Abey, lead consultant, Quality and Regulatory Affairs, Emergo by UL

Dasun Abey has more than 12 years of medical device regulatory experience and technical hands-on experience in medical device design, development and manufacturing. Abey’s background as a biomedical engineer has allowed him to work across a range of device types, including orthopedics, in vitro diagnostic (IVD) devices and high-risk active implantable devices.

In his role as lead consultant for Quality and Regulatory Affairs, he focuses on medical device regulations in the EU, Australia and the U.S. He has managed several MDR and Therapeutic Goods Administration (TGA) submissions and has performed 513(g) requests and Q-Sub (pre-sub) meetings with the U.S. Food and Drug Administration (FDA). His competence further includes creating specific technical documentation, including clinical evaluation reports (CERs) and risk management files.