IVD Survival Guide: Navigating Uncertainty in the U.S. and European IVD Regulatory Landscape

April 5th, 2024
11 a.m. EDT

In vitro diagnostic (IVD) testing has become a cornerstone of modern medicine, with an estimated 70% of medical decisions made based on laboratory test results. Given the vital role IVDs play in guiding care, regulatory agencies frequently review approval requirements and the regulatory frameworks governing these devices are constantly evolving.

The issuance of new regulations, guidance documents, and regulatory proposals make it critically important for IVD developers to proactively navigate uncertainty so they are adequately prepared to mitigate the potential financial, compliance, and operational risks that may surface in a dynamic regulatory environment.

This webinar will cover changes that have been proposed or implemented in US and EU IVD regulations and provide strategies for developers to adapt to the ever-changing landscape.

Topics will include:

  • FDA proposed rule to regulate laboratory developed tests (LDTs) as IVDs
  • FDA reclassification for high risk IVDs
  • Key changes introduced by the EU In Vitro Diagnostics Regulation (IVDR)
  • Current progress on the transition to EU IVDR compliance


Charlie Chrisawn
Executive Director, Diagnostics
Premier Research

Michael Edwards
Sr. Director, Regulatory Affairs, MedTech
Premier Consulting