The rollout of the EU MDR has created new challenges for medical device manufacturers, including those that have had devices on the market for a long time. One area of increased focus is the need to quantitatively establish the clinical benefits to patients from the device based on relevant and specified clinical outcome parameters. This requirement is being strictly enforced by notified bodies and, although this can be straightforward for some types of devices, for others, it can be difficult to define the benefits to the patient.
Unfortunately, most clinical evaluations only focus on clinical safety and performance, and the clinical benefit to the patient is often left out. This results in questions from the notified body and significant updates to the clinical evaluation during the review, which can be stressful and lead to longer review times. Understanding the clinical benefits of your devices and ensuring they are incorporated into your clinical evaluation reports is an essential component of MDR compliance.
Definition of Clinical Benefit
EU MDR Article 2-53 defines a clinical benefit as:
“The positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health.”
In other words, a clinical benefit is essentially the improvement the patient is expected to experience as a result of the device.
It’s important to note that this is different from the performance of the device, which is the ability of the device to achieve its intended purpose. MDCG 2021-6 provides a clear delineation between clinical performance and clinical benefit. However, clinical benefits and performance are related, since as noted in MDCG 2020-6, the clinical performance is the ability of the device to achieve its intended purpose, thereby leading to a clinical benefit. MDCG 2020-6 provides further guidance pertaining to clinical benefits, noting that:
“Clinical benefits may be either direct or indirect; for example devices such as guidewires may assist other medical devices in achieving their intended purpose, without having a direct therapeutic or diagnostic function themselves.”
MDCG 2020-6 also notes that, while direct clinical benefits should be supported by clinical data, indirect clinical benefits may be demonstrable by other evidence, such as preclinical and bench test data, real-world data such as registries, and data from another device that is used with the subject device that does have direct clinical data. For example, the data about a stent can be used to justify the safety and performance of a guidewire.
Examples of Clinical Benefits
Direct clinical benefits are fairly straightforward and usually easier to associate with specific clinical outcome parameters. For example, a total hip replacement has clear and direct clinical benefits to the patient: reduction of pain and improved hip function. These can be measured using various clinical measures, such as Harris Hip Scores.
Indirect clinical benefits, however, are more difficult to define and link to specific clinical outcome parameters. For example, surgical instruments used in a hip replacement procedure don't necessarily have a direct clinical benefit. This is where we look to indirect clinical benefits. The instruments facilitate the procedure, so we can look to the hip replacement procedure outcomes as the indirect clinical benefit.
This is where the second part of the MDR definition for clinical benefits—“or a positive impact on patient management”—is helpful. In these cases, it may make more sense to utilize nonclinical testing, such as usability testing, along with the procedural success rate in the clinical evaluation. For example, the clinical benefit of an implant sizer may be demonstrated by the successful completion of the procedure without any sizing issues. If there were no sizing issues, there was a benefit to the patient by enabling the surgeon to determine the proper size of the instrument in a timely manner, thereby minimizing procedure time and increasing the likelihood of successful performance by the implant.
Practical Tips for Defining Clinical Benefits
Just do it.
The most important tip for defining clinical benefits is simply to do it. If you ignore this part of the regulation, notified bodies will ask why it’s missing. Even if it is challenging to define the clinical benefit from the device, it is important to consider the requirement and have a clear plan for demonstrating either an indirect or direct clinical benefit.
Follow the guidance.
Refer to MEDDEV 2.7/1 rev 4, MDCG 2020-6, MDCG 2020-13, and other guidance documents to help understand clinical benefits and what notified bodies will be looking for in the clinical evaluation.
Check for gaps.
Optimize your technical documentation to ensure that clinical benefits are defined consistently in all of the required areas. There is a lot of crossover in the various documentation required by MDR, and if information is missing or inconsistent, it can lead to more questions from the notified body and longer review times. Take the time to closely review and cross-reference your documentation against the requirements before submitting it to save time and resources.
RQM+ Is Here to Help
Defining clinical benefits is just one piece of the puzzle when it comes to MDR compliance. If your team is overwhelmed or if you want the benefit of the expertise from former notified body leadership on your side, our team is here to help. If you’re struggling with clinical evaluation reports or a particular section of your application or want to make sure you have everything covered, start with our MDR Filtering Tool. This interactive tool allows you to quickly find all references to clinical benefits (and any other topic) in the MDR in every chapter, section, and article.