EU MDR: Tackling Today’s Challenges

When:

Tuesday, June 9 | 1:00 pm - 2:30 pm

Where:

Room 45

Level:

Intermediate

Participant Type:

Product Development, Sourcing/Purchasing, Supply Chain, Quality/Regulatory


The EU Medical Device Regulation (MDR) has presented unique challenges for orthopedic device manufacturers and regulators alike. Gaining clarity on the regulation’s new requirements and ensuring compliant business processes have required significant planning and resources across entire organizations. While the MDR deadline for implementation begins in May 2020, orthopedic manufacturers will be consumed by the new regulation for years to come. Hear from experts from Notified Bodies BSI and TÜV SÜD, as well as representatives of small and large orthopedic manufacturers, as they share their perspectives and lessons learned on the MDR journey. Individual expert presentations will be followed by panel and audience discussion.

Learning Objectives

  • Current status of MDR implementation

  • Recommended approaches to clinical data and clinical evaluation to effectively meet the more stringent equivalence requirements

  • Specific challenges that orthopedic manufacturers face in addressing MDR requirements

  • Lessons learned from large and small orthopedic companies


Moderator

Sharon Starowicz

Regulatory Consultant,

Medical Device

Panelist

Glenda Marsh

Senior Director of Policy Implementation Global Regulatory Affairs Policy and Intelligence,

Johnson & Johnson Medical Devices

Mark Schenk

Vice President of Advanced Solutions and Vice President of Regulatory,

Tyber Medical

Matthias Fink, M.D.

Clinical Reviewer, Clinical Centre of Excellence,

TÜV SÜD

Monisha Phillips, Ph.D.

Global Head, Orthopedic and Dental Devices,

BSI