Transitioning from MDD to MDR: Case Studies, Tips, and Lessons Learned from Large-Scale Implementations of the EU MDR

Tuesday, September 24

4:00 PM - 5:30 PM

Location: 204 B

Learning Level: Strategic

Session Leader(s)

Lisa Casavant, MME

Cofounder and Chief Strategy Officer
Regulatory and Quality Solutions LLC - Enterprise

Speaker(s)

Caroline Byrd

Director Commercial RA/QA
Leica Biosystems Richmond, Inc.
Robert Lally, BSc, MBA, CEng

Senior Director, Regulatory Affairs
Stryker - ENTERPRISE
Patrick McCullagh

Head, Regulatory Affairs, Trauma/CMF/Extremities/Animal Health
DePuy Synthes, Johnson & Johnson
Nancy Morrison, RAC

Director of Regulatory Affairs
Regulatory and Quality Solutions LLC - Enterprise
Ibim Tariah, PhD

Vice President of EU MDR and IVDR Consulting Services
Regulatory & Quality Solutions LLC

Guess what? It’s September 2019! Some notified bodies have been certified to MDR, notified body submission and audits have occurred, and minimal MDD renewal submissions are allowed. How is it rolling out? Do the notified bodies have increased scrutiny? Are medical device manufacturers getting findings for legacy issues not previously identified? Is a lack of clinical evidence causing products to be pulled from the market? Have notified bodies stopped accepting MDD renewals? How are manufacturers responding to all of this and continuing to be successful during this change?

Learn tips and lessons from industry experts who have been in the thick of this since 2017.

Hear directly from those with hands-on EU MDR experience and feedback from notified bodies! The panel will be comprised of notified body representation and companies who started EU MDR implementation planning in Q4 2017 and implementations January 2018; including early pilot submissions to notified bodies. 2018 and 2019 have been packed with large full-scale implementations of all aspects of the EU MDR including preparation of technical documentation submissions pending notified body certifications. These implementations are filled with challenges and interpretation questions.

You will hear stories, best practices, successes, and failures from a cross-functional panel – including a notified body. Aspects include:
• Implementation elements like portfolio reduction
• Optimizing your schedule
• Regulatory file transitions
• QMS changes
• Labeling changes
• Remediation of longstanding issues that will no longer pass
• Training and change management
• …and much more

Hear many examples of findings from the MDR 2018 pilot and 2019 early submissions, as well notified body audit findings related to MDD compliance issues not previously cited.

Prepare to return to your company inspired by real-world examples and ready to act!

Learning Objectives:

Develop strategies to comply with the EU MDR no matter where their company is in the EU MDR transition process.
Impact the development of project plans, schedules, processes, templates, portfolio plans, budgets, and more at their organizations.
Optimize all processes at their organization related to the EU MDR.