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 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

Learn More

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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