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 the complete Performance Evaluation Documentation or one or multiple parts.
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
