AMP Europe 2021: Understanding and Preparing for New IVDR Regulations in the EU: Key Considerations for Clinical Laboratories

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This is a recording of a session from AMP Europe 2021 Virtual Meeting. Purchase a bundle of 8 sessions from the AMP Europe 2021 Virtual Conference for a significant discount by clicking this link.

Session Description:
The EU Regulation 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices (IVDR) was passed on May 26th 2017 and will go into effect in May 2022. IVDR  will replace the EU’s current directive on medical devices and sets force a complex and comprehensive development process, which will require significant time and resources by device manufacturers. These new regulations have significant importance for clinical laboratories, as the exception that allows use of LDTs has been significantly narrowed. IVDR will also affect clinical laboratories worldwide that process European specimens. This session will provide an overview of IVDR and a panel discussion from EU laboratory directors on how they are working to implement IVDR in their laboratories.

Objectives
After this session, participants will be able to:

  • Understand key changes expected in the new IVDR (e.g., scope expansion, risk reclassification) and parallels to proposed regulatory and legislative proposals in the US
  • Identify barriers and issues with implementation for clinical barriers across the EU

Chair: Dr. Hubert G. Niesters

Speakers: Prof. Albrecht Stenzinger, Prof. Giancarlo Pruneri

Duration: 96 minutes
Recording Date: June 15, 2021

Last day to purchase: December 31, 2024

There are no CME or CMLE credits available.

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