Performance evaluation of medical devices is a must for all In Vitro Diagnostic Medical Devices (IVDs) entering the European market. The new European IVD Regulation (EU IVDR), specifically guides manufacturers to conduct performance evaluation of In vitro Diagnostic Medical Devices and submit the Performance Evaluation Report (PER). The PER stands as a key aspect of the overall EU 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 Evaluation
Within the Performance Evaluation Report (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 supporting clinical evaluation of medical device. For successful IVDR compliance, manufacturers of in vitro diagnostic medical devices 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 that manufacturers of in vitro diagnostic medical devices align with IVDR technical documentation requirements, Freyr performs a systematic review of the scientific literature and develops performance evaluation plan along with a compliant Performance Evaluation Report (PER).
- Transition plan for IVDR compliance
- Scientific validity reports based on literature and/or in-house data
- Clinical performance reports based on literature and/or in-house data
- 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 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)