Performance studies

Scientific Validity reports

Clinical & Analytical Performance studies

New requirements of the IVD-R

According to the EU Regulation on in vitro diagnostic products, an IVD Performance evaluation should consist of three aspects:

  • Scientific Validity Report
  • Clinical Performance Studies
  • Analytical Performance Studies


Qarad can provide you with complete or partial Performance Evaluation Documentation.

Our complete package, compliant to the IVD Regulation 2017/746 consists of:

  • A Performance Evaluation Plan and a Performance Evaluation report
  • A Scientific Validity Report based on an in-depth literature study
  • An Analytical Performance Report based on analytical performance studies
  • A Clinical Performance Report based on literature review, clinical performance studies or data of routine use

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