In Vitro Diagnostics
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.