Overview Of Performance Evaluation Report (PER) :
Performance Evaluation is a must for any In Vitro Diagnostic Device (IVD) entering the European market. The new European IVD Regulation (EU IVDR) explicitly guides IVD manufacturers to conduct performance assessments and submit the Performance Evaluation Report (PER). The PER stands as a key aspect of the overall IVDR technical documentation. The purpose of the performance assessment is to produce clinical evidence that supports the manufacturer’s intended use. As per Article 56 (paragraph 3) of the IVDR, a Performance Evaluation must demonstrate:
Expertise
- Within the PER the manufacturer must demonstrate the sufficient clinical evidence that supports the intended use for the device in medical practice, and this wants to be updated throughout the life cycle of the device.
- For successful IVDR compliance, manufacturers are essential to be vigilant all through the performance assessment process that spans across planning, collecting and assessing the clinical evidence data, and making and submitting the Performance Evaluation Report (PER) as part of the IVDR technical documentation.
- To ensure IVD manufacturers align with IVDR technical documentation requirements, Maven performs a orderly review of the scientific literature and progress performance assessment plan along with a compliant PER.
Advantages of Performance Evaluation Reports (PER)
- Cost-effective
- End-to-end Regulatory consultation, of 510(k) Submission Process Consulting, 513(g) Submission Process Consulting, Clinical Evaluation Report (CER), Medical Devices Regulation (MDR), In Vitro Diagnostic Regulation (IVDR) and Performance Evaluation Report (PER)
- Qualified team of experts with hands-on experience across all categories of Medical Devices.
- Expert support for region-specific Regulatory complexities.
- Interactions with Health Authorities (HAs).
- Structured approach to ensure quick product launch or market access
