OCT 28, 2020 6:00 AM PDT

Understanding the IN VITRO DIAGNOSTIC REGULATION (IVDR) Everything You Need to Know

Speaker

Abstract

DATE: October 28, 2020

TIME:  6:00am PDT

 

The new In Vitro Diagnostic Regulation (IVDR) has been defined as one of the most significant changes in the EU legislation for In Vitro Diagnostics in the past 20 years.


Due to the nature of the changes, this cannot be considered just a change in the regulatory system. It affects the majority of the IVD product manufacturing functions as well as the diagnostic laboratories using them. These changes will provide a new classification system, improve traceability, introduce comprehensive post-market surveillance and elevate the scrutiny of documentation.


Diagnostic laboratories need to carefully review their quality system, internal processes and portfolio of products in order to be IVDR-ready by the time the new regulation is implemented.
This webinar will be part of a series that Abbott will be providing, with the end goal of supporting molecular laboratories during this important transition.

 

Learning Objectives:

  • Summarize the differences between the current IVD Directive and new IVD Regulation, including rationale, goals and key changes
  • Understand the impact of IVDR on diagnostic laboratory activities
  • Provide insights on expected changes and key questions to ask manufacturers of IVD products in order for them to be IVDR- ready by May 22, 2022.

 

Webinars will be available for unlimited on-demand viewing after live event.

 

LabRoots is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. By attending this webinar, you can earn 1 Continuing Education credit once you have viewed the webinar in its entirety.


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