Overview Of Performance Evaluation Report (PER)
Performance Evaluation is essential for any In Vitro Diagnostic Device (IVD) entering the European market. The new European IVD Regulation (EU IVDR) guides manufacturers to conduct performance assessments and submit the Performance Evaluation Report (PER). The PER forms a key part of the IVDR technical documentation and demonstrates clinical evidence supporting the intended use.
- Scientific Validity
- Analytical Performance
- Clinical Performance
Expertise
- Demonstrating sufficient clinical evidence to support intended use across the device life cycle.
- Ensuring IVDR compliance through planning, collection, assessment, and submission of clinical evidence in the PER.
- Reviewing scientific literature and preparing a compliant performance assessment plan along with the PER.
Advantages
- Cost-effective
- End-to-end Regulatory consultation covering 510(k), 513(g), CER, MDR, IVDR, and PER
- Qualified experts with experience across all categories of Medical Devices
- Region-specific Regulatory support
- Interactions with Health Authorities (HAs)
- Structured approach for quick product launch or market access
