Scientific Validity Report (SVR) Overview
The Scientific Validity Report (SVR) holds paramount significance within the Performance Evaluation Report (PER) for In Vitro Diagnostic Devices (IVDs), as per the European Union In Vitro Diagnostic Regulation (EU IVDR) 2017/746. The SVR plays a crucial role in scientifically validating the analytical and clinical performance of the device, ensuring the safety and effectiveness of medical devices available in the market. Within the EU IVDR's prescribed conformity assessment process, manufacturers are required to present a PER, which must include an SVR, to a notified body for demonstrating the device's safety and performance prior to its introduction to the EU market.
Scientific Validity Reports for EU IVDR Submission
- Analysis and Conclusions
What constitutes the content of Scientific Validity Report (SVR)?
Scientific validity of an analyte means the association of an analyte with a clinical condition or a physiological state. The scientific validity of an IVD is principally based on one or a combination of the following sources:
Data from all the above as applicable will be drafted in a scientific validity report. By integrating the SVR into the PER, manufacturers elevate their performance evaluation to a higher echelon of credibility. The scientific validity established through the SVR infuses the PER with a robust foundation, enhancing its overall quality and significance. This, in turn, instills confidence in regulatory bodies, healthcare professionals, and end-users, ensuring that the IVD's performance is meticulously evaluated and validated according to the stringent EU IVDR 2017/746 requirements.
Freyr offers comprehensive assistance in preparing a robust Scientific Validity Report (SVR) for IVDs, empowering you to confidently navigate the regulatory landscape and seamlessly introduce safe and effective IVD devices to the market.
- Transition plan for IVDR compliance.
- Scientific Validity Report (SVR) based on literature and/or in-house data.
- Clinical Performance Reports (CPR) based on literature and/or in-house data.
- Analytical Performance Reports (APR)
- Clinical Evidence or Performance Evaluation Reports as per IVDR.
- 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 compliance with recent applicable regulations.
- Team of qualified experts
- Tailored Solutions to your requirements
- Regulatory Resource Management/Staff Augmentation Services
- Cross-functional inputs from Medical Device experts to comply with requirements.