What’s the Difference Between Medical Device Clinical Evaluation and Clinical Performance? We’re Glad You Asked…

In case you need any convincing that many forms of clinical data are a priority for European regulators and Notified Bodies, consider these numbers.

• The EU Medical Devices Directive (93/42/EEC) mentions the word clinical 81 times.
• The MDD’s replacement, the EU Medical Device Regulation (MDR 2017/745), mentions it 677 times.

Yes, I know what you’re thinking the MDR is 3x longer than the MDD but simple math instantly tells you that the days of scant clinical evaluation reports are long gone. Today’s medical device regulatory professional needs to fully understand all aspects of this issue to stay in compliance with European law.

That brings us to our next point. Some of our clients get confused by the various clinical terms tossed around in the EU MDR, MEDDEV 2.7.1 rev. 4, ISO 14971 and other various device-specific standards. It is understandable because the definitions of some of these terms overlap or are confusingly similar. For instance:

• Clinical evaluation and clinical performance
• Clinical evidence and clinical data
• Clinical studies, clinical investigations, and clinical trials

We are not going to dissect all of these terms in this post. Rather, we will focus on two that confuse many regulatory professionals: clinical evaluation and clinical performance.

What Does Medical Device Clinical Evaluation Mean?

The clinical evaluation process has three fundamental objectives:

• Show the acceptable clinical safety of a device.
• Use clinical performance to prove that the device performs as intended.
• Demonstrate that there is a positive clinical benefit versus risk.

According to Article 2 (44) of the EU MDR, clinical evaluation means a systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to a device, in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer (emphasis added).

Let’s break that down:

• Systematic and planned – This means you must document your procedures for conducting a clinical evaluation and show documented evidence of your planning process.
• “Continuously generate, collect, analyze and assess the clinical data” – The key word here is Clinical evaluation is not a one-time activity that occurs when the device is first being developed; it continues throughout the product life cycle. You are always generating data and analyzing that data. Your Notified Body will ask for evidence of this.
• “Verify the safety and performance, including clinical benefits” – This relates to the benefit-risk ratio or benefit versus risk analysis, and is how you meet the General Safety and Performance Requirements (GSPR) of the MDR. Read more about measuring benefits Know More.

So, essentially, clinical evaluation is the process of how clinical data is collected, analyzed, appraised, and summarized from various sources, including clinical literature, clinical investigations, nonperformance data, equivalent devices, and postmarket data.

Medical device clinical evaluation is a process, not a project.

What Does Medical Device Clinical Performance Mean?

Clinical performance is an element of clinical evaluation resulting from the analysis and summary of all forms of clinical data. It is an output of the clinical evaluation process supporting how a device performs as intended, and it happens during Stage 3 of the process.

The word performance often causes confusion, because this can be interpreted as the clinical performance of the device versus the functional attributes and specifications of the device. There can be a lot of variability in the definition of performance in vertical standards, related to specific products. Thus, when you conduct your analysis of clinical performance as part of your clinical evaluation, it is important than you clearly distinguish between these in your technical documentation so your Notified Body does not experience any confusion. As such, you also need to be careful in defining how you associate specific types of data with each definition.

Data can come from a variety of sources, including:

• Device clinical literature
• Clinical trials
• Usability factors
• Equivalent devices
• Postmarket clinical follow-up (PMCF)
• State of the art

Article 2 (52) of the MDR defines clinical performance as the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer.”

Written in layperson’s terms, it means that your device must perform as claimed when used as intended and it has to benefit patients! This should not be confused with clinical safety.

Need Help or Want to Learn More About Clinical Evaluation?

Read up on CERs in our Market Update, Clinical Evaluation Reports 101. In this paper we cover how to create a plan, gather data, and assemble a CER that is compliant with MEDDEV 2.7/1 Rev. 4 and the EU Medical Device Regulation (2017/745).

Sign up for our intensive deep-dive training course on clinical evaluation reports. This training will arm you with the knowledge you need to confidently comply with EU MDR clinical evaluation requirements.

Need immediate help? Our team of EU CER consultants can assist with literature reviews, strategy, and compilation.