MassMEDIC and R&Q Present: Advanced EU MDR and CER Workshop – Boston

Tue, Mar 19 - 08:00

2345 Commonwealth Avenue

Newton, Middlesex County



MassMEDIC and Regulatory & Quality Solutions (R&Q) are partnering to bring you an industry-leading EU MDR and CER workshop event in Boston.

This event will be an extensive yet detailed look at EU MDR and CERs through the lens of top industry experts who have successfully implemented large-scale EU MDR programs and completed 100’s of CERs. RA/QA leaders from multinational medical device companies – along with preeminent RA/QA experts from R&Q – will share invaluable tips and lessons learned from seeing what works first-hand... and what doesn't. You'll have the opportunity to ask questions throughout the day, and will leave the event with an advanced skillset and developed strategies no matter where you are in the EU MDR transition process.

Please see the agenda breakout for specific detail on each session and we hope to see you at the event!
The goal of this event is to educate medical device manufacturers and based on limited seating, we are prioritizing registrations first for medical device manufacturers. If seats remain closer to the event date, we will open up registration to service providers and consultants. Please note the different ticket types.

8:00 – 9:00amArrival, breakfast, networking
9:00 – 10:00amThe State of EU MDR: How did we get here? Presenters:

Ibim Tariah, Technical Director, Medical Devices - BSI [Invited]
Nancy Morrison, Director of Regulatory Affairs - Regulatory & Quality Solutions (R&Q)

The EU MDR date of application is approaching. Quickly. With changing schedules and increased scrutiny from the notified bodies, as well as an overwhelming amount of information available, it can be difficult to understand the impact of the new regulations and determine where and when to start. Your technical files, design dossiers, quality system documents, clinical plans, labeling (including UDI), software, and more will be affected. Plus, new requirements are coming into play, including Eudamed and periodic safety update reports (PSURs).
Compound all of this with varying dates for compliance and the task can seem impossible.
The goal of this session is to help you better understand the major changes coming, the planned timing, how to realistically plan for the impact, and what you can do today to start getting ready. We will also cover what to keep an eye on and provide real-world examples demonstrating what manufacturers and notified bodies are doing because of the changes. Finally, we’ll take a top-level look at tools R&Q has developed to implement the changes.
10:00 – 11:30amTransitioning from MDD to MDR: Case Studies, Tips, and Lessons Learned from Large-Scale Implementations of the EU MDR Panelists:

Ibim Tariah, Technical Director, Medical Devices - BSI [Invited]
Caroline (Leab) Byrd, Director, Regulatory Affairs - Abbott
Alison Philips, Global Program Manager - Boston Scientific
Nancy Morrison, Director of Regulatory Affairs - R&Q

R&Q began EU MDR implementation planning in Q4 2017 and started implementations January 2018, including early pilot submissions to the notified bodies. 2018 (continuing in 2019, of course) has been packed with full-scale implementations of all aspects of the EU MDR and preparation of Technical Documentation submissions pending NB certifications. These implementations were filled with challenges and interpretation questions.
We – along with our industry expert panelists – will share our stories, best practices, successes, and failures related to 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. We have many examples of findings from the MDR pilot submissions, as well as findings from 2018 notified body audits and renewals which were never cited previously. It’s really happening and your organizations must be prepared. We’re compiling technical documentation files now and are preparing planning to submit as soon as the notified bodies are certified.
Prepare to return to your organizations inspired by real-world examples and ready to act, equipped with recommendations for impacting the development of project plans, schedules, processes, templates, portfolio plans, budgets, and more. Ask questions!
11:30 – 12:15pmLunch
12:15pm – 1:15Achieving MEDDEV 2.7/1 Rev. 4 and EU MDR Compliant CERsPresenters:

Jon Gimbel, Director and CER Business Unit Lead - R&Q
Donna Mitchelle-Magaldi, Manager, R.A. Medical Writing - Regulatory Affairs - BD
Jordan Greenberg, Director, Clinical Research, Regulatory (CEP, CER) - Abbott [Invited]

These are clinical stories you’ll want to hear. MEDDEV 2.7/1 Rev. 4 and the EU MDR have raised countless questions in the regulatory and clinical affairs communities. This panel will feature medical device manufacturers and device consultants who have created CERs for products in a wide range of clinical specialties being submitted to a variety of notified bodies. Our panel has seen it all and will share the most impactful lessons learned from every aspect of the CER process. From a strategy for finding data to establishing equivalence to completion of state of the art analyses, the speakers have encountered plenty of obstacles… and found solutions. Industry leaders will discuss case studies featuring a multitude of challenges. For example, what should you do with a low-risk device with no clinical data? What about a device to be up-classed from IIb to III? How much historical information do you need in your CER if this is its first review under the MDR? How will the new EU MDR impact your clinical evaluations? Like we said, countless questions! Attendees will return to their organizations with actionable ideas and recommendations to impact decisions and apply plans on how to address the requirements.
1:15 - 2:15Post-Market Surveillance Under EU MDR Presenters:

Nancy Morrison, Director of Regulatory Affairs - R&Q
Jon Gimbel, Director and CER Business Unit Lead - R&Q
Jordan Greenberg, Director, Clinical Research, Regulatory (CEP, CER) - Abbott [Invited]

What is ‘sufficient clinical evidence’ and what does it look like as part of PMS? The EU MDR lays out requirements for a proactive post-market surveillance system that inputs into the ongoing risk management and clinical evaluation processes throughout the device lifecycle. This session will address options for sufficient clinical evidence and the opportunities, risks, and challenges associated with each. Additionally, in this session, we’ll cover requirements for PMS planning and PMS reporting for all classes of devices. With significant new requirements for device-specific plans and reports, you’ll need to update your post-market surveillance system with enough time for your staff to implement the changes. The requirements seem to overlap with the CER requirements. How can you optimize your process to take avoid duplication of efforts? Are you really ready?
2:00 – 3:30pmPost-Market Surveillance Panel: Case Studies, Tips, and Lessons LearnedPanelists:

Florianne Torset-Bonfillou, Director of Regulatory Affairs and Education - Lead Auditor - GMED North America
Ron Sills, Lead Auditor - Medical - TUV Rheinland - North America
Nancy Morrison, Director of Regulatory Affairs - R&Q
Jon Gimbel, Director and CER Business Unit Lead - R&Q
Jordan Greenberg, Director, Clinical Research, Regulatory (CEP, CER) - Abbott [Invited]

3:45 – 6:00pmNetworking socialLocation to be determined.

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