The IVDR (In Vitro Diagnostics Device Regulation) requests manufacturers to show the scientific validity, analytical presentation as well as the clinical performance of the device for its intended use.
The IVDR constitutes the performance evaluation of in vitro diagnostic (IVD) devices as a constant procedure, comparable with the clinical performance evaluation method defined by the MDR (Medical Device Regulation).
The IVD performance evaluation report includes the results as well as methods concerning, analytical performance, scientific validity as well as clinical performance. Performance evaluation for in vitro diagnostic medical devices is a vital procedure as well as serves to meet the necessary security as well as performance needs of IVDR.
From the IVDR perspective, clinical evidence should support the intended principle of a device as stated by the manufacturer as well as that is based on performance evaluation. This is lead through a PEP (performance evaluation plan) as well as a clinical facts file that should be combined as a PER (presentation evaluation report).
A preview of the IVDR performance evaluation report template, you may view it as important for a large number of reasons, however, the overarching goal is to stop false negatives or false positives, both of which may have detrimental physical as well as psychological impacts on the patient.
The Utilization Of In Vitro Diagnostic Medical Devices
The idea of in vitro diagnostic medical devices (IVDs) is to supply information from human samples, including blood and tissue that allows conclusions to be drawn about, for example, physiological or pathological processes in the body.
VD manufacturers must provide proof of an IVD’s clinical benefit based on data on scientific validity, analytical performance as well as clinical performance. Scientific validity refers to the association between the analysis and the disease or physiological state.
Why is the Performance Evaluation Report Required?
There are few elements that must be included in every performance evaluation plan. They include, however, are not restricted to:
- Performance terms of the IVD
- Intended utilize or aim of the device
- List of recorded facts for the device
- Indications for utilization, limitations, as well as contra-indications
- The GSPR (General security as well as Performance Requirements) supported by your performance evaluation
- List of analytical tests carried and what standards are used
- Intended target patient groups
- Marker to be utilized
It is important that you spend plenty of time preparing this map because it will finally save you time when you actually finish the performance evaluation.
