DAY TWO | WEDNESDAY, JULY 17

8:30 REGISTRATION & WELCOME COFFEE

8:55 CHAIRPERSON’S OPENING REMARKS
Derk Arts, MD, PhD, Founder and CEO, CASTOR

9:00 ESTABLISHING COMPLIANT PARTNERSHIPS WITH ECONOMIC OPERATORS
Updating a company’s internal processes is a major aspect of MDR implementation, but regulatory professionals must also work to ensure compliant partnerships with economic operators, both the ones internal and external to the manufacturer’s corporate group, as these now have their own independent regulatory responsibilities under the MDR. Manufactures rely on importers and distributors for their products to reach the market uninterrupted by compliance issues and a noncompliant partnership can introduce serious risk to a product’s viability and a company’s economic health. Delegates will hear how to avoid these complications with importers, distributors and authorized representatives throughout the entirety of the supply chain to ensure MDR compliance.

Erik Vollebregt, Partner, AXON LAWYERS

 

9:45 THE EU MDR APPROVAL PROCESS: BEST PRACTICES FOR IDENTIFYING TOXIC SUBSTANCES
Travis Miller, General Counsel, ASSENT COMPLIANCE

 

10:30 COFFEE AND NETWORKING BREAK

 

REDESIGNING APPROACHES TO EUROPEAN CLINICAL EVALUATION: MULTI-PART LEARNING MODULE
The framework of the European Medical Device Regulation (MDR) redefines the acceptable thresholds of clinical evaluation requirements for medical technologies, placing a much heavier burden on manufacturers and requiring robust levels of clinical evidence in order to meet certification levels. While manufacturers recognize the need for greater intensity of evidence, defining the appropriate amount of data is nebulous, resulting in considerable uncertainty surrounding the amount of investment required for re-certification, particularly for legacy products where access to equivalency data is restricted. Providing multiple perspectives and case studies, presentations within this module will provide a level of benchmarking for industry executives with concerns surrounding appropriate clinical evidence, along with notified body perspectives clarifying the regulatory approach to clinical evaluation data meeting certification requirements.

 

11:00 PART 1: INDUSTRY CASE STUDIES ON ALIGNMENT OF CLINICAL RESEARCH WITH MDR FRAMEWORK

  • Balancing evidence generation against risk profile
  • Preparing & documenting evaluation criteria
  • Development of documentation & templates

Cory Marsh, Manager, Regulatory Operations, MERIT MEDICAL

 

11:45 PART 2: APPROACHES TO LEGACY PRODUCTS WITH LIMITED AVAILABILITY OF EQUIVALENCE DATA

  • Evaluating evidence for class III products
  • Leniency in evidence for class IIa & IIb
  • Interpretation of “sufficient” product data

Dona Occhipinti, EU MDR Clinical Evaluation Lead, HILL-ROM

 

12:30 LUNCHEON FOR ALL ATTENDEES

 

1:30 PANEL: NOTIFIED BODY INTERPRETATION OF APPROACHES TO CLINICAL INVESTIGATIONS & EQUIVALENCY

  • Development of enhanced clinical evaluation frameworks
  • Recommendations on data formatting & documentation
  • Product-class specific requirements for evidence
  • Interpretations of sufficient equivalence for legacy products

MODERATOR: Christopher Mauch, KPMG

PANELISTS: Dr. Matthias Fink, TÜV SÜD

Allison Weiser, Manager, INTEGRA LIFESCIENCES

Dr. Alexandra Schroeder, BSI

 

2:15 LEARNING MODULE: IN-DEPTH ANALYSIS OF EU MDR IMPACT ON LABELING OPERATIONS

PART ONE: UPDATING LABELING SYSTEMS & INFRASTRUCTURE TO INCORPORATE EU MDR
Current and future medical device labels must comply with the EU MDR, which is a significant undertaking for regulatory professionals and requires a multitude of resources. Key provisions within the regulation specific to labeling include expanded requirements and initiatives towards increased transparency and traceability. As these requirements will be rigorously enforced as of May 2020, regulatory and labeling teams must collaborate and begin to implement these new standards as soon as possible.

  • Strategic approaches for ambiguous labeling requirements
    • Symbols
    • UDI
    • IFU
  • Forecasting resources and costs necessary for updating systems
  • Balancing new requirements with other global label mandates

Roger Peterson, Manager, Global Labeling Systems, ARTHREX

 

3:00 COFFEE AND NETWORKING BREAK

 

INITIATING ROBUST POST-MARKET RISK MITIGATION UNDER THE EU MDR FRAMEWORK
A primary intent of the development of and transition to the EU MDR has been to reduce the risks associated with medical products accessing the European market, to provide safeguards for consumers as well as enhance the overall safety of products in the market. The documentation of product safety does not end upon certification, and the MDR framework incorporates rigorous post-market safety and surveillance requirements creating an additional obligation for industry manufacturers in the market. Blending industry perspective on practical implementation alongside notified body interpretation of requirements, attendees will gain a solidified picture of the requirements for future product monitoring and surveillance.

 

3:15 PART 1: INDUSTRY CASE STUDY
Adam Grimshaw, Corporate EU MDR Risk Management Lead, HILLROM

 

3:45 PART 2: NOTIFIED BODY INTERPRETATION
Dr. Alexandra Schroeder, Product Expert and Scheme Manager, BSI

 

4:15 KEYNOTE FIRESIDE CHAT: NOTIFIED BODY INTERPRETATIONS OF THE EU MDR
Limited regulatory guidance from competent authorities and the European Commission has resulted in notified bodies taking center stage in the interpretation and implementation of the MDR, with medical device manufacturers creating close ties with these important stakeholders. Certification timelines and audit expectations are a constant concern for regulatory directors, who rely on the interpretations from notified bodies in the absence of implementing acts. In an interview-style session, participants will have a chance to clarify these areas by engaging a panel of notified body representatives directly with pre-submitted questions, gaining valuable perspective on a variety of MDR concerns, including clinical evaluation interpretations, reclassification of devices and the internal notified body designation process.

MODERATOR: Sophia Rubalcaba, RCRI/COVANCE

PANELISTS:
Dr. Matthias Fink, TÜV SÜD

Dr. Alexandra Schroeder, BSI

Ibim Tariah, BSI

 

5:00 END OF CONFERENCE

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