Understanding the Regulatory Landscape for Diagnostic Tests

RU Okay? Understanding the Regulatory Landscape for Diagnostic Tests in the US, UK and EU

Overview


Join us for an informative discussion on the evolving landscape of In Vitro Diagnostics (IVD) and Lab Developed Tests (LDTs). Our panel of industry leaders will delve into the latest developments from across the US, UK and Europe.

REGISTER

3:00 – 4:00 pm (GMT)
4:00 – 5:00 pm (CET)
10:00 – 11:00 am (EST)

Complimentary Webinar

Agenda


  • The FDA’s proposed rule on LDTs issued in September 2023 – what will this mean for test providers and manufacturers?
  • The landscape for Research Use Only and LDTs in the US, UK and Europe – what are the current exemptions?
  • EU IVDR timelines and extensions – the current transition and understanding when a change is significant
  • Compliance with the new standards – what do you need to know about clinical evidence and timelines to certification?
  • The UK IVD current landscape and the timelines for proposed new regulations – what flexibility is there?

SPEAKERS


Alex Laan, Head of the IVD Notified Body, BSI

Stephen Lee, Director, Diagnostics Regulation, ABHI

 

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