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webinar

MedTech Digital Week 2023 – How is IVDR Impacting Precision Medicine Clinical Trials Today?

- by James Lappin

Explore the EU In Vitro Diagnostic Regulation (IVDR) and its impact on IVD clinical trials. Get insights on key IVDR concepts, performance study requirements, CE marked device usage, Annex XIV application specifics, and the in-house exemption (Article 5(5)). Prepare for successful clinical trials in the EU.

This webinar covers the following elements:

  • IVDR implementation, key definitions and timelines
  • Basic requirements for IVD performance studies
  • Using CE marked devices in performance studies and clinical trials
  • Annex XIV – IVD performance study application requirements
  • The In-house exemption (article 5(5))

James Lappin
Article written by James Lappin
October 30, 2023
CTA

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