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EUROPEAN IVDR ROADMAP

$49.00

This lecture presents the roadmap of the new European regulation for in vitro diagnostic medical devices and provides an orientation to navigate all the key changes. Learn all you need to know for a successful transition to the new legislative framework. Easy guidelines are provided to get ready on time!

Description

This lecture presents the roadmap of the new European regulation for in vitro diagnostic medical devices and provides an orientation to navigate all the key changes. Learn all you need to know for a successful transition to the new legislative framework. Easy guidelines are provided to get ready on time!

 

TOPICS

  • In Vitro Device Regulation (00:02:40)
  • Fundamentals (00:00:47)
  • Timelines & Grace Period (00:02:59)
  • Common Specifications (00:01:09)
  • IVDR Key Changes (00:01:40)
  • Classification (00:03:03)
  • Conformity Assessment (00:03:52)
  • Performance Evaluation (00:04:07)
  • PMS & Vigilance (00:02:05)
  • Technical Documentation (00:01:15)
  • Person Responsible for Regulatory Compliance (00:01:15)
  • Device Identification & Tracebility: UDI (00:02:54)
  • Registration of Economic Operators (00:01:15)
  • EUDAMED (00:01:16)
  • Risk Management System (00:04:26)
  • Corrigenda (00:01:57)
  • Impact on Industry (00:02:04)

  • Final Test – European IVDR Roadmap
  • Certification

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