EU MDR Workshop Agenda:
Day 1

THURSDAY, NOVEMBER 21, 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 - 8:40 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.

Facilitator:

  • Michelle Rich, Associate Director of Program Development, Xavier Health, Xavier University


8:40 AM - 9:20 AM

Setting the Stage: The Solution Xchange

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.

Facilitators:

  • Michelle Rich, Associate Director of Program Development, Xavier Health, Xavier University

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


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 (in case still relevant….) around Brexit.

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.

Facilitators:

  • Stephanie Lauman, Global Director, Product Development and Lifecycle Management, bioMérieux

  • Lindsay Taylor, Director, Regulatory Affairs, Abbott

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


11:25 AM - 12:25 PM

Lunch


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.

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.

Facilitator:

  • Gert Bos, Executive Director & Partner, Qserve Group


2:55 PM - 3:15 PM

Break


3:15 PM - 4:00 PM

Supply Chain and Distribution Chain Impact

As companies implement solutions needed to prepare for the vast EU MDR changes, impact to the supply chain cannot be overlooked.  The concept of Risk-Management as set in ISO 13485:2016 needs to be established throughout the Supply Chain, and includes:  risk related to: patient & user safety (ISO 14971:2019); usability (IEC 62366-1/A1:2019); cybersecurity (many standards!); manufacturing of devices in conjunction with services and components deriving from a supplier, and other risks. Without including supply chain risk management in your risk strategy, your product and patients remain vulnerable. The expert facilitators will share successful systems engineering practices for how to ensure completeness when discovering and mitigating Hazardous Situations for Medical Devices during Risk Management, and how to communicate effective Risk Control needs (Specifications) with suppliers.

Facilitator:

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


4:00 PM - 5:00 PM

EUDAMED and Unique Device Identifier Requirements

This session will cover how to comply with the requirements to submit data into EUDAMED, and include discussions of the new UDI requirements. It will also cover the progress of the various guidance to be produced and issued by the EU commission. Importantly , we will explore the role of EUDAMED and how the system can work in anticipation of EUDAMED being fully functional.

Facilitator:

  • Gert Bos, Executive Director & Partner, Qserve Group