Free

Medical Alley and R&Q Present: Advanced EU MDR and CER Workshop – Minnesota

Event Information

Share this event

Date and Time

Location

Location

DoubleTree by Hilton Hotel Minneapolis - Park Place

1500 Park Place Boulevard

Minneapolis, MN 55416

View Map

Event description

Description

The Medical Alley Association and Regulatory & Quality Solutions (R&Q) are partnering to bring you an industry-leading EU MDR and CER workshop event in Minnesota.

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.




Agenda

8:00 – 9:00am
Arrival, breakfast, networking

9:00 – 10:00am
The State of EU MDR: How did we get here?
Presenters:

  • Ibim Tariah, Technical Director, Medical Devices - BSI
  • 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 – 11:30am
Transitioning 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
  • Caroline (Leab) Byrd, Director, Regulatory Affairs - Abbott
  • Karen Rittle Leigh, PhD, International Regulatory Manager - 3M
  • Nancy Morrison, Director of Regulatory Affairs - R&Q

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 EUMDR experience and feedback from notified bodies! The panel will be full of 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. 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!

11:30 – 12:15pm
Lunch

12:15pm – 1:15
Achieving MEDDEV 2.7/1 Rev. 4 and EU MDR Compliant CERs
Presenters:

  • Jon Gimbel, Director and CER Business Unit Lead - R&Q

As of September 2019, MEDDEV 2.7/1 Rev. 4 and EUMDR compliance is now mandatory for your CERs! In 2019 notified bodies have refused to certify products with gaps in clinical evidence, incomplete PMCF, and poorly written CERs. Attendees need to understand what is really happening. You will hear real-life stories to take back to your companies to light the fire to get your CERs updated, start studies if needed, and close the gaps. These are case studies you’ll want to hear.

This session will feature medical device manufacturers and device consultants who have created Rev. 4 and MDR compliant 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.

Our speakers have encountered plenty of obstacles… and found solutions. In this session, learn how other manufacturers and experts have addressed closing their CER gaps and achieving compliance. In 2019 notified bodies have refused to certify products with gaps in clinical evidence, incomplete PMCF, and poorly written CERs. You need to understand what is really happening. You will hear real-life stories to take back to your companies to “light the fire” to get your CERs updated, start studies if needed, and close the gaps.

Industry leaders will discuss case studies featuring a multitude of challenges. For example:

  • Notified Bodies will review your submission as if it is the first time; what does that mean?
  • What should you do with a low-risk device with no clinical data?
  • What should you do with a device to be up-classed from IIb to III?
  • How much historical information do you need in your CER for first review under the MDR?
  • What if our PMCF is incomplete?

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 - 2:15
Post-Market Surveillance Under EU MDR
Presenters:

  • Nancy Morrison, Director of Regulatory Affairs - R&Q
  • Jon Gimbel, Director and CER Business Unit Lead - R&Q

What is ‘sufficient clinical evidence’ and what does it look like as part of post-market surveillance? 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 post-market surveillance planning and post-market surveillance 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 – 3:30pm
Post-Market Surveillance Panel: Case Studies, Tips, and Lessons Learned
Panelists:

  • Ron Sills - R&Q (former 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

Requirements for post-market surveillance have changed drastically under EU MDR. Manufacturers can no longer rely on a simple procedure to meet post-market surveillance requirements and cannot use a system that applies generally to all devices – manufacturers must consider unique aspects of individual devices and how that may impact their post-market surveillance. Additionally, the post-market surveillance must be an integral part of your clinical evaluation and risk management process. Data must flow between CERs, risk management, and post-market surveillance which challenges departments in large companies to communicate like they never have before. How do manufacturers implement all of this?

In this session, we will address the challenges manufacturers face implementing EUMDR requirements for post-market surveillance. Expert panel discussion will include the following questions:

  • How to implement the requirement in a simple, straight forward manner
  • How to integrate CERs, PMS, and risk management processes – and in what order!
  • Trend reporting strategies – what will be acceptable?
  • Do we include all CAPAs in reporting? Or include a small subset in the PSUR?
  • How detailed will our complaint reporting be? What should be assessed and how much to include?
  • Post Market Clinical Follow Up (PMCF) – what does it take to justify not doing it?

3:45 – 6:00pm
Networking social
Location to be determined.

Share with friends

Date and Time

Location

DoubleTree by Hilton Hotel Minneapolis - Park Place

1500 Park Place Boulevard

Minneapolis, MN 55416

View Map

Save This Event

Event Saved