Under EU MDR, What Are the “Starting Point” and “End Point” of Clinical Evaluation for the CER?

Under EU MDR, Have You Correctly Defined the “Starting Point” and “End Point” of Clinical Evaluation for the CER?

Following our previous article on Clinical Claims in the EU clinical evaluation Article 61(10) performance route and their critical role, many readers have been quite confused about what exactly clinical claims are. What kind of claim qualifies as a clinical claim? To be candid, even among colleagues on global teams in some of my previous practical work, there were differing views on this question. This shows that this is not only a point of confusion for peers in China, but also for professionals overseas. So today, let us explore together what kind of claim can be considered a “Really clinical claim”, and whyan “appropriate/suitable” clinical claim is both the “starting point and the end point” of the CER.

Today’s discussion will mainly focus on the following topics:

1. Why does a CER need a clear and well-defined clinical claim?

2. What are the EU MDR requirements for clinical claims in the CER?

3. Are clinical claims related to clinical benefit and clinical performance?

4. How can we distinguish a true “clinical claim” from a false one?

5. Why is the Clinical Claim considered the “starting point and end point” of the CER?

1. Why should a CER have a relatively clear and explicit Clinical Claim?

Before answering this question, first consider the following: why do you conduct a clinical evaluation for your device? For sure, beyond “meeting/complying with” the requirements of the EU MDR, the essence of clinical evaluation is todemonstrate the safety and performance/effectiveness of our device, and in addition, provide actual “Evidence/Clinical Evidence”todemonstrate “what your device can do / to what extent your device can perform / what meaningful benefits your device can deliver”. So, to get back to the point, this is why your device needs a relatively clear and explicit Clinical Claim, because it is the device’s “value proposition.” In other words, your CER is about scientifically, logically, and evidence-based demonstrating the “core value proposition” of your device. (I understand this clearly myself, but I am not sure whether I have explained it clearly.)

2. What does the EU MDR require for the Clinical Claim in a CER?

3. Is the Clinical Claim related to clinical benefits and clinical performance?

In discussingBefore discussing Clinical Claim, Clinical Benefits, and clinical performance, let us first look at their definitions below:

As shown in the figure above, the last sentence explains the relationship among the three, because

❤️ The Clinical Claim rooted in the original intent

👉 a device that delivers the corresponding claimed clinical performance (or performance)

👉 thereby generating the intended clinical benefits sought by the manufacturer and beneficial to patients,

Therefore, this“three-part sequence”must be clearly defined in the CER and its related technical documentation (TD), and more importantly, supported by sufficient evidence. Therefore,the CER is not just about “what you said”; it is an interlinked process of using evidence to demonstrate that “what you said is justified.”

4. How do you assess whether a “Clinical Claim” is valid?

Before giving examples, one point should be clarified: the same device may have non-clinical claims or clinical claims; the key question is whether you can substantiate your claim with sufficient evidence.

A. Let us start with a very simple example. For a basic scalpel, if your clinical claim is that it cuts/dissects tissue to facilitate the procedure, then this is a non-clinical claim and can also be understood as a performance claim. The intended claim is only to achieve the intended function/capability/ability, and the patient benefit is only an indirect clinical benefit, because the ultimate success of the surgery, or the clinical outcomes, is not determined by the scalpel itself.

B. The same applies to a scalpel, but if the clinical claim is that it cuts/dissects tissue and can reduce procedure time by XX%, then such a claim is a clinical claim, because the scalpel affects procedure time and in turn affects patient clinical benefit (positive impact).

Based on this typical example, the real point is that when making a Clinical Claim, please “think twice” and consider the broader impact. We learned this the hard way: because a Clinical Claim went beyond the intended purpose, extensive remediation was required—revising the IFU, marketing materials, data sheets, and all related TD documents. The most difficult part is when the product has already been on the market for many years: how do you withdraw your TD for revision? Therefore, before making any claim, first set a clear objective for yourself—you must have sufficient evidence to support your claim, not merely assert it.

C. Here are two more examples:

A surgical suture is the first choice of 95% of physicians?

A CT device can provide CT images with higher contrast?

Please consider whether these two claims are Clinical Claims, and let me know your answer in the comments.

5. Why is the Clinical Claim described as the “starting point and end point” of the CER?

Finally, returning to the main topic, why do we saythat the Clinical Claim is both the “starting point” and the “end point” of the CER? There are two dimensions to this,From the perspective of device R&D and design, the original intent behind designing your device was not only to establish a presence in the market, but also to provide benefits. Those benefits may be for patients or users, and they may be direct or indirect. Therefore, the claim (whether a clinical claim or a non-clinical claim) is the“the original intent” or “the selling point”, so you want to design a device that matches the “selling point” you expect; the other is fromthe regulatory perspective, or, from a clinical evaluation perspective, precisely because you want to claim what your device can do, you need to mine sufficient evidence based on the claims in your intended purpose to support and substantiate those claims. So the claim you want to make is only the starting point, while the ultimate endpoint or focus of the CER still serves that claim; that is, you prove what your device can do or to what extent it can do it, and while it can achieve its intended purpose, you must also ensure an acceptableBenefits-Risk Ratiobenefit-risk balance—that is, patients should not incur harms greater than the benefits they receive; the above is whyThese are my personal thoughts on why a Clinical Claim is the “starting point” and “endpoint” of a CER. I hope I explained it clearly and that you found it helpful～

Feel free to follow along or leave a comment to discuss