Do you still struggle to define your clinical claims?

As many of you know, the definition of clinical claims (performance, safety and benefits) in the CER has become even more rigorous under the MDR.

“Claim” is not directly defined in the EU MDR, but a contextual definition can be inferred from how the term is used. For the most part, the term “claim” is linked to intended purpose, safety, performance and clinical benefit (i.e., clinical claims) Article 7 of MDR 2017/745.

? Claims established outside of these areas are not clinical claims and may be considered “marketing or non-medical/technical claims”

The MDR limits what the manufacturer can claim in Article 7:

Any claims made on a medical device may not mislead the user or the patient with regard to the device’s intended purpose, safety, and performance. In this article, there are examples of types of misinterpretation of facts that should not occur:

?? Functions and properties that the device does not have

??False impression regarding treatment or diagnosis, functions or properties

??Lack of information of the user/patient on likely risks in line with the device’s intended purpose

??Suggesting uses outside the intended purpose (other than the one for which conformity assessment has been done)

The challenge for the manufacturers is that they need to consider all the potential claims that are presented in brochures, pictures, and websites.

Performance Claims

EU MDR Article 2(52) defines the clinical performance as:

“Clinical performance means 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”.

Let's see some examples.

The table below shows the poorly defined performance claims.

Be aware that the claimed performances above cannot be demonstrated by clinical evidence, therefore, avoid using such claims in your CER for medical devices on the market.

Suppose the medical device is not CE-marketed yet. In that case, you can include such technical performance claims enabling you to understand the mechanism of actions, support the claimed equivalence and investigate the interaction between the human body and medical device.

In some cases, claims are based on non-clinical testing and bench testing (as in Art. 61.10 of MDR) if they do not cover clinical safety or performance.

After the CE mark, the manufacturer needs to consider how any changes made to claims on clinical performance and safety may affect the clinical evaluation of the device. The good news is that you can still adjust your claims in the updated CER, but make sure to add a notice that the claims have been adjusted and you can conduct the clinical evaluation of the device.

Sometimes, marketing claims develop their own life and cannot be adequately substantiated by the SOTA or technical studies.

Experience has shown, however, that the notified bodies readily question such claims.?

Good Performance Claims:

VAS – Visual Analog Score

If you claim that the medical device reduces the pain, then you can quantify the pain reduction with the VAS score (see image below). If the clinical data shows that the VAS score decreases by the claimed value, then the clinical benefit is proven.

Final Thoughts: NBs expect a clear definition of clinical claims. Therefore, keep your documentation up-to-date, and always prioritize the benefits and patient safety.

If you need support and guidance or just want to discuss your claims or CER, feel free to reach out to me!