EU MDR Workshop Agenda:
Day 1

WEDNESDAY, MARCH 27, 2019

 

8:00 AM - 8:30 AM

Breakfast

Join your colleagues from around the world as we kick off the EU MDR Workshop with a complimentary warm breakfast.


8:30 AM - 8:50 AM

Let's Make a Difference! 

Welcome to the workshop and welcome to Xavier University. Highlight of why the topic is so crucial at this stage. This purpose-driven workshop will lead you to actionable learning and implementation plans.

Lead Facilitator:

  • Marla Phillips, Director, Xavier Health, Xavier University


8:50 AM - 9:20 AM

Setting the Stage: The Solution Exchange

Start your day with solutions! This fast paced, engaging session draws out your experience and ideas by having you work collaboratively with your colleagues. Address the challenges that will be discussed throughout the workshop, while tying your ideas to the hopes of a patient whose life is depending on you.

Lead Facilitators:

  • Oliver Christ, Executive Vice President, PROSYSTEM, an NSF International Company

  • Marla Phillips, Director, Xavier Health, Xavier University


9:20 AM - 10:20 AM

New Discoveries and Moving Forward

This session will help you understand where Europe is moving with its legislation, and why. We will then enhance your understanding with cutting edge interpretation and implementation, from the vantage point of working with many company sizes, many product types, and many unique scenarios. Importantly, we will explore the impact of unclarities such as lack of designated notified bodies, unfinished databases and templates, and the uncertainties around Brexit.

Lead Facilitator:

  • Gert Bos, Executive Director & Partner, Qserve Group


10:20AM - 10:40 AM

Break


10:40 AM - 11:25 AM

Advanced Strategies to Effectively Work with Notified Bodies

As we approach the implementation deadlines for the EU medical device regulations, manufacturers have many concerns about the accessibility of their products to the patients they serve. We will explore how the overall relationships between manufacturers and notified bodies have evolved during this process and where we stand in terms of designation. We will take a practical approach to how you can address the challenges you face related to renewal of certificates in advance of the derogation period, and how you can best prepare. During this session, you will be engaged in dialog on real life challenges, such as how to plan for and anticipate a capacity issue, what to do if your notified body is not designated in time, or its scope does not cover your devices.

Lead Facilitator:

  • Philippe Auclair, Pharmacist, Ph.D., Senior Director, Regulatory Strategy and Advocacy, Abbott Quality and Regulatory


11:25 AM - 12:25 PM

Lunch Networking by Topic

Engage in lively discussions with your colleagues and the workshop facilitators at tables dedicated to topics that are important to you as you enjoy your lunch together.


12:25 PM - 1:55 PM

Insightful Game Plans for Compiling the Data Required to Certify Your Products

Article 7 of the medical device regulation (MDR) clearly explains the legal responsibility of medical device manufacturers to substantiate any claim with evidence. It says that in the labeling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance. On the other side, Article 61 of the MDR says that conformity with relevant general safety and performance requirements set out in Annex I of the regulation shall be based on clinical data providing sufficient clinical evidence for the device when used under normal conditions as intended. During this session, we will explore various methodologies to prove whether the list of claims is supported by evidence fulfilling the requirements of Annex I for various examples of devices with different class risks.

  1. Are the claims transparent and consistent?

  2. Are you aware of any claims made by your marketing department globally?

  3. Do you update your website regularly?

  4. Do you know how your device is achieving its intended purpose?

  5. Do you state clearly whether the evidence has a bench, pre-clinical or clinical origin?

  6. Do you consider in your clinical evaluation plan all planned and defined claims for your device?

  7. Etc.

Lead Facilitator:

  • Bassil Akra, Vice President, TÜV SÜD Product Service


1:55 PM - 2:55 PM

Strategic Product Portfolio Assessment

This session will focus on the various elements that contribute to the wishes, the possibilities and impossibilities of removing legacies from your portfolio prior to implementing an MDR transition plan. Through case study examples, you will be engaged in exploring the elements of core EU products, legacy sale out, and the effect of market approvals outside of the EU.

Lead Facilitator:

  • Gert Bos, Executive Director & Partner, Qserve Group


2:55 PM - 3:15 PM

Break


3:15 PM - 4:15 PM

Effective Post-Market Surveillance

Lead Facilitator:

  • Kim Trautman, Executive Vice President, Medical Device International Services, NSF


4:15 PM - 5:00 PM

Supply Chain and Distribution Chain Impact

Lead Facilitators:

  • Oliver Christ, Executive Vice President, PROSYSTEM, an NSF International Company

  • Kim Trautman, Executive Vice President, Medical Device International Services, NSF


EU MDR Workshop Agenda:
Day 2

THURSDAY, MARCH 28, 2019

 

8:00 AM - 8:30 AM

Breakfast

Enjoy a complimentary warm breakfast as we begin the second day of the EU MDR Workshop.


8:30 AM - 10:00 AM

Reporting Requirements to the EU Commission

This session will cover the post market requirements under the Regulations and how to comply with the future system. It also will cover the progress of the various guidance to be produced by the EU commission and timeline for finalization. Importantly , we will explore the role of EUDAMED and how the system can work in anticipation of EUDAMED being fully functional.

Lead Facilitator:

  • Philippe Auclair, Pharmacist, Ph.D., Senior Director, Regulatory Strategy and Advocacy, Abbott Quality and Regulatory


10:00 AM - 10:20 AM

Break


10:20 AM - 11:50 AM

Navigating the Gray: Developing Successful Solutions

This interactive session will enhance your ability to plan for and manage the many uncertainties and unclarities in the EU MDRs. Although the basics are clear, interpretation of the intent and how to meet the intended expectations is far from ready. Join this session to understand how to move forward in this landscape of challenges in a way that you are confident that you have done what you can to be in compliance. With the implementation of tools largely unfinished, we will explore how to successfully address the challenge of hitting a moving target.

Lead Facilitator:

  • Gert Bos, Executive Director & Partner, Qserve Group


11:50 AM - 12:50 PM

Lunch Networking by Topic

Engage in lively discussions with your colleagues and the workshop facilitators at tables dedicated to topics that are important to you as you enjoy your lunch together.


12:50 PM - 2:20 PM

Affecting Improvement Across Your Enterprise

As the workshop comes to a close, there are a lot of learnings you will need to put into action when you return to work so you can affect change in your organization that will protect your patients and your business. Since collaboration is key, how you communicate this information is critical. During this session, you will be engaged in a simulation that will help you put this into action. Build a plan with your peers of what you would communicate to the Board of your company, then get ready for an exciting role playing game!

Lead Facilitators:

  • Gert Bos, Executive Director & Partner, Qserve Group

  • Kim Trautman, Executive Vice President, Medical Device International Services, NSF


2:20 PM - 2:50 PM

Break


2:50 PM - 3:50 PM

Fireside Chat with the Experts

Our panel of expert speakers will take your questions and will do the impossible: help you prepare for the unknown! In a world of uncertainty as it relates to the EU MDRs our expert panel members will take your questions in an informal, collaborative setting that gets to the heart of your most pressing challenges. Don’t miss this opportunity to engage with experts and your industry colleagues in a session to remember.

Lead Facilitator:

  • Philippe Auclair, Pharmacist, Ph.D., Senior Director, Regulatory Strategy and Advocacy, Abbott Quality and Regulatory


3:50 PM - 4:00 PM

To Your Success!

Thank you for joining us, and we look forward to staying engaged with you throughout your journey for the benefit of the patients you serve.

Lead Facilitator:

Marla Phillips, Director, Xavier Health, Xavier University