White Paper: Performance Data and EU IVDR: Improving Operational Efficiencies Through Compliance

Performance Data and EU IVDR 2022 JULY_Paper FrontThis white paper was updated July 2022.

Written by Carlos Galamba, RQM+ Vice President, IVD Intelligence and Innovation, this white paper discusses EU IVDR clinical evidence requirements and how manufacturers can efficiently comply.

Underestimating the time required to source the right clinical evidence for your products could result in costly approval delays or removal from the market.

If you can leverage existing clinical evidence from diagnostic products that are 510(k) cleared in the U.S., you could have a head start.

THIS WHITE PAPER COVERS:

  • Clarification on the clinical evidence required for IVDR compliance
  • Synergies between EU and U.S. requirements that could save you time
  • A detailed summary of clinical evidence requirements under IVDR
  • A checklist to assess whether key information is included in your PER

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