Practical implications of the new EU MDR and ISO 14971 on post-market surveillance

The Final Draft International Standard (FDIS) of the 3rd Edition of ISO 14971 is now in its final stages and is expected to be published in August of 2019. Due to the far-reaching impact of this standard, which is a normative reference in the vast majority of standards used throughout the medical industry, manufacturers and other interested parties will be reviewing the document in detail to understand the impact. Coincidentally, this is all occurring within the shadow of another significant change for medical device manufacturers – implementation of Europe’s new Medical Device Regulation. 

One of the areas of change in both the ISO 14971 3rd Edition FDIS and the EU MDR is the subject of post-market surveillance. Accordingly, a prudent course of action is to review both documents to ensure alignment of any process changes an organization may be considering. To that end, this webinar will explore production and post-production processes supporting risk management of medical devices, including elements of a Quality Management System (such as ISO 13485) that are frequently used in risk management. 

In this one-hour webinar, we will discuss: 

  • Establishing a plan for the device production and post-production phase 
  • Plan elements, and P&PP activities expected 
  • Tailoring surveillance proportionate to risk and device type 
  • Clinical Performance, Clinical Benefit and Benefit-Risk Determination 
  • Real-world approaches to ensure understanding of device risk in the P&PP phase 
  • Data implications and actions arising from its analysis 

Mark Leimbeck is a Program Manager for UL Health Sciences with more than 30 years of experience working in roles including Operations Manager, Program Manager, and Principal Engineer. He is responsible for developing new services, training, and representing UL on International standards and other technical development committees. Mark holds a bachelor’s degree in Electrical Engineering Technology from Southern Illinois University and a master’s degree in Business Administration from the University of Chicago.