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Notified Body designation and scope, the impact of Brexit and Competent Authority and Notified Body interpretation of the regulations. Make sure you are up to date!

EU IVDR Preparation and Implementation - MedTech eBook Series

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Explore or download the eBook by clicking on the image above (or here).

With the EU IVD Regulation Date of Application now just 18 months away, time is running out for IVD manufacturers to prepare for these major changes in the IVD approval process.

Here in this interactive eBook, MedTech Summit has gathered together insights from industry, Notified Body and Competent Authority perspectives on IVDR preparation and implementation. We have full recorded sessions from TÜV SÜD, the Association of British Health-Tech Industries, and Medicon Hellas SA, plus an overview of how well prepared IVD professionals are, with exclusive data from a study we ran earlier in 2020.

Contents

  • Time is Ticking on Preparations for the New EU IVDR: Jo-Ann Fabila Gonzales, Director, In Vitro Diagnostics & Quality at Precision for Medicine, offers an overview of the changes coming and strategy to prepare for them.
  • REPORT: IVDR Readiness: Explore exclusive data on how prepared the industry is for IVDR implementation from our survey report.
  • NOTIFIED BODY UPDATE: EU IVDR Implementation: Andreas Stange, Vice President MHS global IVD at TÜV SÜD, gives an update on IVDR implementation.
  • COMPETENT AUTHORITY PERSPECTIVE: Practical Considerations for Preparing for the EU IVDR: Stephen Lee, Director of Diagnostic Regulation at the Association of British Health-Tech Industries.
  • Industry Preparations for the EU IVDR: Alexandra Stamati, Director, Quality Assurance-PRRC at Medicon Hellas SA, offers a guide to the requirements and process of preparing for EU IVDR from the perspective of industry.

Explore or download the eBook by clicking on the image above (or here).

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