The EU MDR requires significantly larger amounts and different types of both premarket and postmarket device safety and performance data. In addition to more rigorous clinical information and active collection and analysis of postmarket experiences – for legacy devices as well as new products – new processes and governance will be needed to support this assessment and ongoing file updates. In this highly interactive, practical workshop, companies and notified bodies share strategies and procedures for approaching these massive changes.

Topic Outline

Implementation Timeline

  • Why EU MDR and the emphasis on clinical requirements
  • Timelines and deadlines
  • Overview of major areas of impact

MDD vs MDR – Overview

  • Key differences
    • Active data collection
    • Clinical evidence requirements
    • Rules on equivalence
    • Closer alignment with PMS and risk assessment
    • Continuous updating
    • More interactions with notified bodies
    • Impact on labeling, and publicly available information
  • Gap analysis

Clinical Evaluation Report (CER)

  • Elements of the CER
  • Creating a clinical evaluation plan covering the product life cycle
  • General Safety & Performance Requirements (GSPR)
  • Benefit-risk
  • Integration with risk management, postmarket surveillance, and other functions
  • Consideration of currently available alternative treatment options
  • Review by outside entities

Equivalence

  • Acceptable data for supporting equivalence
  • Challenge of access to data on equivalents
  • Notified body review

Clinical Investigations

  • When are clinical investigations required
  • Aligning clinical investigations with the CEP
  • Rationale for study design, endpoints, variables, etc

Risk Management

  • Benefit-risk under EU MDR
  • Relationship with other risk standards and requirements
  • Linkage of risk management, clinical evaluation, PMS, PMCF, and PSUR
  • Challenges and strategies for new and legacy devices
  • Updating the risk file, risk acceptability, and detecting emerging risks

Eudamed and Labeling

  • What must be included on labeling
  • Summary of clinical and performance data
  • Implications of new clinical evidence requirements for labeling, instructions for use
  • Submitting data to Eudamed
  • Use of Eudamed data

Postmarket Surveillance

  • Comparison of MDD vs MDR postmarket surveillance
  • Active data collection
  • Identifying potential input sources
  • Surveillance proportionate to risk and device type
  • Adverse event reporting
  • Gap analysis in current and future procedures

Post-market Requirements

  • Postmarket Clinical Follow-Up Studies (PMCF)
  • Continuously monitor state of the art
  • Mechanisms to understand benefit-risk estimates, emerging off-label use, etc.
  • Periodic Safety Update Reports (PSUR), analysis of postmarket information, and update of benefit-risk, clinical evaluation, etc.
  • Does the device perform as intended?
  • Documentation and PMCF Evaluation Report
  • Linkage of postmarket data with other functions
  • Triggers and techniques for actions

Processes and Governance

  • Establishing new processes and governance structure
  • Relationship with other company functions

EU MDR Supply Chain & Economic Operators

May 20 - 21, 2019
A Virtual Conference

Learn More

EU MDR Clinical & Postmarket Surveillance Strategies

May 21 – 22, 2019
A Virtual Conference

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EU MDR Labeling, IFU, UDI, & Eudamed

May 23 - 24, 2019
A Virtual Conference

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Pricing

We offer Team, Enterprise and multi-conference Discounts.
Veronica Allen, Conference Manager can help you select the right discount plan for you and your organization.

Register Today!

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