IVDR Performance Evaluation Report Form
Complete this structured form to report and assess the performance of an IVDR device or test according to regulatory standards.
Device/Test Name
*
Device/Test Identifier (Model/Batch/Serial)
*
Evaluator Name and Role
*
Date of Evaluation
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Intended Use/Clinical Context
*
Please Select
Screening
Diagnosis
Monitoring
Prognosis
Other (specify below)
Performance Criteria Evaluation
*
Rows
Poor
Fair
Good
Excellent
Analytical Sensitivity
1
2
3
4
Analytical Specificity
5
6
7
8
Reproducibility
9
10
11
12
Robustness
13
14
15
16
Ease of Use
17
18
19
20
Were any deviations or issues encountered?
*
No deviations/issues
Minor deviations/issues
Major deviations/issues
Summary of Findings
*
Overall Performance Conclusion
*
Meets all performance requirements
Meets most requirements with minor issues
Does not meet requirements
Recommendations/Next Steps
Submit Report
Should be Empty: