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Complimentary Virtual Conference

July 17, 2019 | 11:00 a.m. - 3:15 pm EDT

Requirements & Implementation

The EU Medical Device Regulation (EU MDR) require more than a few new SOPs. A profound overhaul of the regulatory approach in one of the world’s largest medical device markets, the EU MDR demands new procedures, evidence development, documentation, relationships, reporting, data management, and a reevaluation of legacy portfolios. Senior management should be involved in strategic planning for changes that can significantly affect a company’s business.

This complimentary, four-hour virtual conference, conducted by leading experts on EU MDR requirements and implementation, provides concise insights into key aspects of the regulation to help companies understand and plan for the impending changes.

Learning Objectives:

During this event, you will learn about:

• EU MDR provisions and timeline
• Strategic considerations and priorities
• The business impact of compliance

• New clinical evidence requirements
• Changes in postmarket surveillance
• Requirements for economic operators
• Supply chain considerations
• Labeling, IFU, and UDI requirements
• Risk management provisions
• Eudamed database reporting requirements
• Remediation of legacy devices

Who Should Attend:

• Senior management
• Clinical
• Postmarket
• Compliance
• Legal
• Supply Chain
• Global strategy


11:00 am – 11:05 am  Welcome and Introduction
Maria Fontanazza – Editor-in-Chief, MedTech Intelligence.Com

11:05 am – 11:30 am Implementation Overview
Dr. Basssil Akra, Vice President, Strategic Business Development, Global Medical Health Services, TÜV SÜD

  • Can we make it in time?
  • Do we have enough Notified Bodies? Will we get an extension?
  • How should we manage scheduling our TD reviews to MDR will our NB aned scheduling our MDR audits (especially for small/medium size manafucturers?)

11:30 am – 12:00 pm Strategies for addressing the unknowns around what product changes can be made in the soft transition?
Keith Morel, Ph.D., VP Regulatory Compliance, QServe Group

  • Strategies on how to deal with ambiguity of what changes can be made in soft transition

12:00 pm – 12:30 pm Clinical Data Evaluation under MDR
Carolyn McCuan, Consultant, QServe Group US, Inc.

  • Practical experience from writing CEP/CERs to meet MDR
  • Common pitfall/mistakes/gaps we see
    • Scoping is poor; no CEP; Lit. search requirements not met; clinical outcomes not clear/not defined; don't have data to support all claims; PMS/PMCF insuffient; equivalence argument not convincing
  • How to address those (techniques/examples used)
  • Other lessons learned/important points you've picked up in your practise in this past year or so as we prepare for MDR.

12:30 pm - 12:45 pm HealthLink Europe Technology Spotlight
Kay Bonavita, VP, Sales, HealthLink Europe & International

12:45 pm – 1:15 pm PMS
Carol  Romero, Associate Manager, Quality Programs, Stryker Neuro 

  • PSUR creation
    • Timing/content (including usage, patient population)
    • Getting the information needed
    • Defining roles and responsibilities between departments/functions
    • Analyzing the data and drawing conclusions, holistically, across various data sources
    • Connecting with other plans and reports in the QMS
    • Timing and connecting with CER (per class)

1:15 pm – 1:45 pm Automating the various plans-reports needed under MDR - Managing the content tsunami
Marc Miller, Division President,TransPerfect Medical Device Solutions

  • Automating the PMS-PMCF-CEP-CER-SSCP plans and report content creation

1:45 pm – 2:10 pm EU MDR, UDI, Labeling - Regulatory Requirements
Mark Cusworth, VP, Research & Development, PRISYM ID

  • EU MDR label requirements compared with MDD and AIMDD
  • Label - before and after EU MDR
  • Comparison of EU MDR & FDA UDI
  • EU MDT Labeling solutions

2:10 pm - 2:35 pm Economic Operators
Nic Pugliano, Regulatory Affairs - Medical Products, W. L. Gore & Associates, Inc.

  • How can large manufacturer handle the various verifications that the manufacturer, importer and distributor need to perform and avoid duplication?
  • Should Economic Operators be maager through the Supplier Management process within the QMS (ISO 13485:2916 clause 7.4?

2:35 pm - 3:00 pm Eudamed
Richard Houlihan, CEO, Eudamed Ltd.

3:00 pm – 3:15 pm Questions and Answers

All Faculty

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