Performance evaluation is a must for any In Vitro Diagnostic Device (IVD) entering the European market. The new European IVD Regulation (EU IVDR) specifically guides IVD manufacturers to conduct performance evaluations 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 evaluation is to produce the clinical evidence that supports the manufacturer’s intended use. As per Article 56 (paragraph 3) of the IVDR, a Performance Evaluation must demonstrate:
- Scientific Validity
- Analytical Performance
- Clinical Performance
Within the PER the manufacturer must demonstrate the sufficient clinical evidence that supports the intended use for the device in medical practice, and this needs to be updated throughout the life cycle of the device.
For successful IVDR compliance, manufacturers are required to be vigilant all through the performance evaluation process that spans across planning, collecting and assessing the clinical evidence data, and preparing and submitting the performance evaluation report (PER) as part of the IVDR technical documentation.
To ensure IVD manufacturers align with IVDR technical documentation requirements, Freyr performs a systematic review of the scientific literature and development performance evaluation plan along with a compliant PER.
- Transition plan for the IVDR compliance
- Scientific Validity reports based on literature and/or inhouse data
- Clinical Performance Reports based on literature and/or inhouse data
- Clinical Evidence or Performance Evaluation reports (PER)
- Performance Evaluation Plan
- Post Market Performance Follow up (PMPF) protocols and Reports
- Post Market Surveillance (PMSR) Protocols and Reports
- Writing/revising other documents such as package insert/IFU, Quick Reference Instructions (QRI), operation/user manual etc.
- Assured IVDR compliance, IVD registration, and CE marking
- Proven expertise for IVDR technical documentation
- Strong Regulatory understanding and expertise in EU IVDR key impact areas
- Strong project management driven delivery model to ensure schedule adherence
- Inhouse NB Experts (review of the report by NB interactive reviewers)
- Focused teams with cross expertise on specific impact areas and device categories
- Cross-functional inputs from medical device experts to comply with requirements
- Full-scope of service across compliance, review, and planning
- Strong expertise in maintaining consistency in deliverables (Time and Quality)