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Potential impact of IVDR on diagnostic testing in Europe – What are the implications for the pharmaceutical industry?

Read our latest blog on “Potential impact of IVDR on diagnostic testing in Europe – What are the implications for the pharmaceutical industry?”

Written by Joe Clune, CDx commercialization consultant and Stewart McWilliams,  VP of Quality and Regulatory Affairs at Almac Diagnostic Services, the blog covers the following key topics:

  • Introduction to IVDR
  • IVDR – What’s New?
  • Challenges in the implementation of IVDR
  • Background – Companion Diagnostics
  • The evolving landscape of approved tests vs LDTs
  • Will Europe still have LDTs with IVDR?
  • What does Pharma need to do?
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