Performance Evaluation Report

The performance evaluation is an assessment and analysis of data to establish or verify the scientific validity, the analytical performance and, where applicable, the clinical performance of a device. The Performance Evaluation Report (PER) gathers and assesses all that information allowing demonstration of the clinical evidence.

The PER shall in particular include, amongst others: 

  • The justification for the approach taken to gather the clinical evidence,
  • The literature search methodology, protocol and report of a literature review,
  • The technology on which the device is based, the intended purpose of the device and any claims made about the device’s performance or safety,
  • The nature and extent of the scientific validity and the analytical and clinical performance data that have been evaluated,
  • The clinical evidence as the acceptable performances against the state of the art in medicine,
  • Any new conclusions derived from Post-market Performance Follow-up (PMPF) reports.

How can DDR help?

  • DDR will assist companies in preparing the PER by delivering a literature search and choosing those studies considered supportive.
  • Furthermore, our team can search for an equivalent IVD to explore its path to certification. In the event that a Clinical Performance Study is needed, DDR will ensure compliance with regulation.
  • We may also compile all the documentation and elaborate the PER for the Technical Documentation to be assessed by a Notified Body.

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