Overview

  • What information must be made available to whom in what form?
  • What the EU intends to accomplish through changes in labeling, IFU, UDI, and Eudamed
  • General industry concerns
    • Timeline
    • Cost
    • Proprietary information

Labeling

  • Comparison of labeling under MDD and MDR
  • Required label contents
    • Warnings and precautions
    • Directions to summary of clinical evaluation
    • Declarations of carcinogenic, mutagenic, or reproductive toxicity
    • Reprocessing information on single-use devices
    • Standardized symbols
    • Identification of economic operators
    • Lingering uncertainties about labeling requirements
    • Need for label redesign
    • Deadlines and strategy

Instructions for Use

  • Content requirements
  • Guidelines for use of plain language easily understood by end users, including the summary of clinical evaluation

Translations

  • Language requirements
  • What must be translated
  • Increased manufacturer responsibility for translation oversight

UDI

  • UDI placement
  • UDI-DI and UDI-PI
  • Currently unresolved potential differences between EU, FDA, and other UDI field formats and relations
  • The UDI database – status and procedures
  • Gap analysis and preparation for new UDI requirements

Websites

  • Requirements to list device labeling, IFU, and technical manuals

Eudamed

  • Establishment of Eudamed under MDD
  • Great expansion of Eudamed requirements under MDR
  • Eudamed implementation and enforcement timeline
  • Product data that must be submitted to Eudamed
  • Standardized nomenclature allowing comparison of different devices in the same group
  • To whom is Eudamed information accessible?
  • Responsibility for entering the data
  • Quality management systems modifications necessary to store and update required information

EU MDR Risk Management

April 6-7, 2020
Virtual Workshop

This two half-day virtual event features presentations and panel discussions by speakers from notified bodies and top medical device companies.

Topics covered:

  • Introduction and Overview - Risk Management and the EU MD
  • ISO 14971:2019 – Overview and Applicability to EU MDR and other regions
  • Design and Usability Requirements with respect to EU MDR
  • Practical application of Risk Management for EU MDR
  • EU MDR and Post Market Surveillance Requirements
  • EU MDR additional Monitoring and Trending Requirements
  • Post Market Surveillance methods and best practices
  • Post Market Surveillance and Risk Management
  • Application of Risk Management for Post Market Surveillance and Trending
  • Tying it all together - EU MDR / Risk Management / Post Market Surveillance

Pricing

We offer Team, Enterprise and multi-conference discounts. Pricing for each virtual workshop is available on each workshop page. 
Veronica Allen, Conference Manager can help you select the right discount plan for you and your organization.

Register Today!

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