Virtual Program: Key Challenges in Preparing for EU Medical Device Regulation (MDR)

RAC Credits
Thursday, 06 December 2018 (11:00 AM) - Thursday, 06 December 2018 (4:00 PM) (Eastern Time (US & Canada))
6 December 2018
11:00 – 4:00 pm EST
Registration Information
Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.

RAPS Members: $ 499
Nonmembers: $ 575

The new European Medical Devices Regulation (MDR) was published in May 2017 to improve the safety and efficacy of medical devices in the EU. This regulation replaces two of the existing medical device directives by 2020. The transition window for compliance with MDR is rapidly closing, manufacturers need to be making urgent progress in addressing changed requirements and generating supporting evidence needed to for both new and existing legacy CE Marked AIMD/MDD devices. Regulatory affairs professionals with responsibility for European devices can’t afford to wait until all the supporting guidance documents and expectations are fully clarified, it is important to make assessments now to anticipate how to address new requirements while there is still enough time to generate the information, balancing how much is expected to be enough with the expense of doing too much.  

This program will be focusing on key areas requiring significant effort to evaluate and update to maintain access to the European marking such as understanding clinical data expectations, generating clinical evaluation reports, updating technical documentation and preparing for enhanced post-market requirements.

Learning Objectives:
  • Understand the impact of the new clinical requirements on clinical evidence
  • Understand new expectations of clinical evaluation reports 
  • Understand the technical documentation required to demonstrate compliance
  • Understand enhanced post-market expectations
Who Should Attend:  
  • Medical device regulatory affairs staff responsible for compliance, submissions, clinical and post market of products intended for Europe
  • Consultants and suppliers supporting medical device regulatory affairs staff
Learning Levels: Basic, Intermediate

Sameer Jaiswal, PRP Consultant
Laurel Macomber, worldwide director of clinical evaluation, Johnson & Johnson Medical Device Companies
Mindy McCann, vice president of regulatory compliance, Qserve Group
Keith Morel, vice president of regulatory compliance, Qserve Group