The most demanding requirements imposed by EU IVDR concern clinical and performance evaluation, even of legacy products, and stringent ongoing postmarket assessments. Some confusion remains about procedures and expectations, and our speakers discuss best approaches and strategies.

Topics to be addressed include:

  • Performance evaluation to show scientific validity, analytical performance, and clinical performance
  • “Sufficient clinical evidence”
  • Demonstrating clinical utility
  • Postmarket surveillance plan to monitor key safety, performance, and risk elements
  • Postmarket performance follow-up studies (PMPF)
  • Periodic safety updates and clinical evaluation throughout the product lifetime Incident reporting and trending

Invited Speakers:

  • Jon Marion, Associate Director, Clinical Quality, Abbott
  • Peter O’Blenis, CEO, Evidence Partners
  • Caroline Byrd, VP of Regulatory, Quality & Clinical, Nextern
  • Alex Charitou, Associate Partner, EY
  • Cindy Ballas, IVDR Project Lead, Ortho Clinical Diagnostics

Click here for additional information and registration details.

Related Content

Evidence Matters 2022

Evidence Matters 2022

Evidence Matters is a virtual one-day summit that brings the literature review community together from different industries to learn, engage, and solve ever-pressing evidence-based research challenges.