Clinical Evaluation vs Clinical Performance
What Does Clinical Evaluation Mean?
Three fundamental goals are the focus of clinical evaluation:
· Demonstrate acceptable clinical safety for a device.
· To prove the device's performance, use clinical performance.
· Prove that there is a positive clinical advantage over risk.
According to Article 2 (44) of the EU MDR, "means a systematic, planned process to continuously create, collect, analyze, and assess the clinical data pertaining a device, in verifying the safety and performance of the device, including the clinical benefits when it is used as intended by its manufacturer."
Let's take a look at it:
"Systematic, planned" - You must document the procedures you use to conduct a clinical assessment and provide documentation of your planning.
"Continuously create, collect, analyze, and assess the clinical information"- This keyword ‘Clinical evaluation’ does not end with the initial device being developed. It continues throughout its lifecycle. Therefore, you are constantly analyzing and generating data. Your Notified Body will request this.
Verify safety and performance, including the clinical benefits. This refers to the benefit-risk ratio or benefit versus risk analysis. It is how you meet the MDR.'s General Safety and Performance Requirements of the MDR. That has more information about measuring benefits.
Clinical evaluation of medical device refers to the collection, analysis, appraisal, and summary of clinical data from various sources, including clinical literature, nonperformance data, and equivalent devices and post-market data.
What Does Clinical Performance Mean?
Clinical performance refers to the outcome of clinical evaluation based on the analysis and summation of all clinical data. It results from Stage 3 clinical evaluation that supports how a device performs according to its intended performance.
The term performance is often misunderstood. This refers to the device's clinical performance, not its functional attributes or specifications. In addition, the definition of performance can vary widely depending on the product. Therefore, you must differentiate these terms in your technical documentation when conducting your clinical evaluation. This will ensure that your Notified Body does not experience confusion. You must also be precise in linking specific data to each definition.
Data can be derived from many sources, including:
· Clinical literature for devices
· Clinical trials
· Factors that improve the usability
· Equivalent devices
· Post-market clinical follow-up (PMCF).
· State-of-the-art
ACCORDING TO THE MANUFACTURER, the MDR Article 2 (52) defines clinical performance as "... the ability of a device to achieve its intended purpose.
It means your device must perform according to the specifications when it is used in a way that benefits patients. This should not be confused for clinical safety.
Do you need immediate assistance? Need immediate assistance? Our CER consultant team can help with literature reviews, strategy, and compilation.
Related - What do you mean by Clinical Writing?
