Performance Evaluation under EU IVDR
General Background
According to Annex XIII of Regulation (EU) 2017/746 In Vitro Device Regulations (EU IVDR), performance evaluation is the continuous process of assessing and analyzing relevant data demonstrating the scientific validity, analytical performance and clinical performance of the subject device(s) in accordance with its intended purpose.
To conduct performance evaluation, the manufacturer must first draw up a performance evaluation plan. The performance evaluation plan includes the device characteristics, intended performance, the process for identifying and generating clinical evidence. The performance evaluation shall be thorough and objective, considering both favorable and unfavorable data. Performance evaluation should be proportionate and appropriate to the nature of the device including the risks, risk class, performance and its intended purpose.
A performance evaluation report (PER) is a document that assesses all relevant scientific validity, analytical and clinical performance data to verify the conformity of its device with the general safety and performance requirements as referred to in Annex I of EU IVDR. The PER shall include the scientific validity report, the analytical performance report, the clinical performance report and an assessment of those reports allowing demonstration of sufficient clinical evidence.
The stages of performance evaluation can be summarized as:
- Performance evaluation plan
- Demonstration of the scientific validity and the analytical and clinical performance
- Data identification
- Data appraisal
- Data analysis
- Performance evaluation report
The evidence presented in the PER will be used to determine the benefit-risk of the device based on the risk, intended purpose, analytical performance, clinical benefit, clinical evidence and clinical performance. The quantity and quality of data collected should allow for a qualified assessment whether the IVD will achieve the intended clinical benefit and safety, when used as intended.
The PER and associate clinical evidence shall be updated throughout the life cycle of the device with data obtained from post-market performance follow-up (PMPF).
Support & Training
Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below.
Key points
Our Services
Training
AKRA TEAM provides training regarding general Performance evaluation and PER writing as well as specific topics regarding state of the art, performance evaluation strategy, PMPF planning and more.
Process and Templates Development
Proven procedure and document templates are available for all aspects of performance evaluation including:
- Performance evaluation procedure
- Performance Evaluation Plan
- Performance Evaluation Report
- Literature Search Protocol/Report
- State of the art (SOTA) structure
Gap Assessment
AKRA TEAM offers comprehensive gap assessments of performance evaluation documentation to highlight areas of risk or improvement prior to submission. AKRA TEAM will rank risks from high to low while offering mitigations to close any identified gaps.
Implementation
AKRA TEAM has an experienced team of medical writers, clinicians and regulatory experts available to write performance evaluations and related documentation for all device categories and risk-classes. We offer custom tailored solutions or comprehensive solutions to addresses the needs of any manufacturer. Additionally, if the performance evaluation is currently under review we can provide targeted updates based on any open deficiencies.
Continuous update of documentation
AKRA TEAM additionally offers solutions for continuous documentation updates. Akra Team will schedule and revise documentation at defined intervals to ensure regulatory compliance is maintained according to the expectations of EU IVDR.
Interested in our services?
Lorem ipsum dolor sit amet, consec tetur adipis cing elit. Ut elit tellus, luctus nec ullam corper mattis, pulvinar dapibus leo.