The EU MDR requires a novel level of oversight throughout the entire supply chain – supplier, manufacturer, authorized representative, importer, and distributor. Economic operators incur added responsibilities and are subject to greatly increased scrutiny. This new flow of responsibility for monitoring compliance necessitates changes in contractual agreements and organizational structures. In this highly interactive, practical workshop, companies and notified bodies share strategies and procedures for approaching these massive changes.

Topic Outline

The Challenge

  • Rationale for changes in the regulation – previous problems
  • Need for oversight throughout the supply chain
  • Current provisions vs MDR – key differences
  • Timelines and deadlines

Supply Chain – Selection Criteria

  • New tax and other economic factors affecting supply chain organization
  • Selection criteria under 13485:2016 & MDR
  • Documentation

Supply Chain – Data Requirements

  • General Safety and Performance Requirements (GSPR)
  • Technical information requirements
  • Hazardous substances
  • Software and cybersecurity

Supply Chain – Agreements

  • Regulatory and quality responsibilities
  • Unannounced audits
  • Useful conversations with suppliers about MDR implementation
  • Model contracts

Economic Operators

  • Definitions and responsibilities
    • Manufacturer
    • Importer
    • Distributor
    • Authorized Representative
  • Relative responsibilities of each economic operator
  • New internal capabilities of economic operators

Verification of Regulatory Compliance

  • Responsibility for verification of the previous link in the supply chain
  • Who is responsible and how much for what?
  • Complaint handling
  • Non-conformances
  • Risk mitigation
  • Evaluation of manufacturer
  • Verification of conformity assessments
  • Managing corrective actions
  • Agreements with manufacturer on postmarket surveillance
  • Documentation of regulatory compliance assessment
  • Reporting requirements and mechanisms
  • Recall responsibility
  • Traceability requirements and UDI

    • Whose responsibility
    • Record keeping

    Contractual arrangements with Economic Operators

    • EO selection
    • Contractual agreements

    Business Strategy, Planning, and Budgeting

    • Structuring the project
    • Review of existing relationships
    • Creation of systems for implementation and ongoing management
    • Resource requirements
    • The cost of compliance

    EU MDR Implementation Strategies

    November 6-8, 2019
    Virtual Workshop

    The new EU Medical Devices Regulation (EU MDR) will profoundly affect the medical device market in Europe. Implementation deadlines are rapidly approaching. Companies that have not already made significant progress in planning and preparation may be at risk of losing EU product registrations. With notified bodies and consultants understaffed and overcommitted, help will be hard to find. Anyone can read the regulation, but interpretation remains vague in some areas, and even the best prepared companies have large teams struggling with impact analysis, strategy, budgeting, and implementation. This three half-day virtual event features presentations and panel discussions by speakers from notified bodies and top medical device companies. Pooling knowledge and strategies will help the industry as a whole better plan for the massive and costly upcoming changes.

    Register Now!

    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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