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 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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