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Claims and their proof in the clinical evaluation

In connection with the MDR, “Claims” refer to claims or statements made by manufacturers about the intended use, performance or benefit of a medical device. These claims may include a wide range of aspects related to the product, including the intended purpose, application indications, efficacy, safety and any other features that may be relevant to the performance or benefit of the product. Claims relevant for clinical evaluation can be found in the technical documentation, but also often in marketing documents, etc.

The MDR, but also the FDA, for example, require that every claim can be objectively proven, e.g. with clinical data. The “proof” of claims is often a challenge that should not be underestimated.

In this article we would like to give you the answers of our expert Prof. Michael Imhoff on the many exciting questions presented by our customers:

PMCF – Clinical Data for Post-Market Clinical Follow-Up

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Your question:

“Is the application of a membrane for the laparoscopic technique also formulable as a technical claim? For example: The small product size, as well as the non-gluing with yourself, allows laparoscopic application“
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Answer by Prof. Michael Imhoff

“Yes, definitely. In this case, reference is made only to the technical properties of the medical device. And no statements are made regarding clinical outcomes.”

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Your question:

“Can you give an example of the detection of clinical claims about technical evidence and inference from SOTA?”
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Answer by Prof. Michael Imhoff

“The statement that intensive ventilators can be life-saving is certainly a very strong clinical claim. However, the scientific evidence of the last 70 years, the guidelines and the relevant textbooks, say that positive pressure ventilation can actually be life-saving. And DIN EN ISO 80601-2-12 states that the ventilator that meets this standard is suitable for performing positive pressure ventilation adequately. And if my ventilator meets this standard, it is also clear that – like all other ventilators compliant to the standard – it can actually be life-saving with proper indication and application by the user. To do this, we do not need a clinical trial with this ventilator.”
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Your question:

“Does it make sense to define a strategy to select and prove claims in the quality management system?”
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Answer by Prof. Michael Imhoff

“Basically, that makes sense. However, you should be careful not to put too much into a scheme. But it certainly makes sense, for example, to stipulate that all claims can be stored centrally and only obtained from there.”
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Your question:

“Can further claims be phrased over the lifetime of a device if the clinical data allow it or, for example, further clinical data are available?”
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Answer by Prof. Michael Imhoff

“Of course that should be possible. Some claims, e.g. a claim regarding shortened treatment duration or lower treatment costs, require data that can typically only be obtained with a broader use of the medical device. And, of course, new insights can also be used to support new claims.”
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Your question:

“Do all claims (clinical, technical) have to be proven in the context of clinical evaluation? Or just clinical claims?”
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Answer by Prof. Michael Imhoff

“In principle, all claims must be demonstrated in clinical evaluation. However, we recommend and practice that the technical claims with reference to technical verification are already identified in CEP and are no longer covered in detail in CER.”
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Your question:

“Do I understand correctly that the technical claims should already be listed in the Clinical Evaluation Plan (CEP)?”
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Answer by Prof. Michael Imhoff

“In the CEP, all, both technical and clinical claims should be listed. We recommend and practice that the technical claims with reference to technical verification are already identified in CEP and are no longer covered in detail in CER.”
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Your question:

"According to MDR 61(10) you have to prove the technical claims with non-clinical data in the CE - why can you simply "omit" the technical claims in a non-61(10) clinical evaluation?"
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Answer by Prof. Michael Imhoff

“The technical claims CANNOT be omitted. However, they can be treated separately from the clinical claims. Some of the aspects have been covered in the previous answers.”
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Your question:

“To what extent must sources of technical claims be publicly visible? In particular: are references to internal documentation allowed/needed?”
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Answer by Prof. Michael Imhoff

“Nothing in the CEP/CER must be made public (except the information that is in the public part of the SSCP). CEP and CER are confidential documents. And in any case, references to technical (internal) documentation are not only possible but also necessary. However, the CE should remain readable and understandable in itself."
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Your question:

“I find it difficult to distinguish technical from clinical claims. The most relevant example of a technical claim on the low risk of infection by antimicrobial coating. For example, in hydrocephalus shunt therapy, the infection rate is one of the largest and most important outcomes in the literature. How can it be said that a claim to the reduced risk of infection can only be technically proven by using a coated catheter? How do I show that infection rates in the patient are ultimately really reduced?”
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Answer by Prof. Michael Imhoff

“In your example of an implant, you certainly can’t get around clinical (study) data from this medical device to prove such a claim. The moment I make concrete statements about directly patient-related outcomes, I will usually have to prove this with clinical data as well. However, when it comes to such things as the reduction of germ counts on surfaces (e.g. with regard to the risk of cross-infections) or the availability of procedures to disinfect endoscopes or to sterilise instruments, such a claim will often be proven purely technically.”
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Your question:

“How do you document the claims to be proven post-market in the product file upon approval?”
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Answer by Prof. Michael Imhoff

“I would use these claims in a central location (e.g. “Claims-Master”) with the reference to the planned evidence. But in clinical evaluation, these claims should not appear until they are really made and can be proven.”

Our service for you:

Do you need support with your PMCF activities? Our experts are happy to help you and support you, for example, in the collection and evaluation of clinical data or the continuous independent collection and evaluation of clinical data, in the conduct of PMCF studies, the development of a PMCF study design or the preparation and updating of regularly updated reports on safety and the safety report (PSUR).

Please contact us at info@qtec-group.com and arrange a free consultation.

 
qtec group | Delvyn Heinsch CTA| qtec-group

Claims and Clinical Evaluation? We Can Help.

Because of the many requirements under MDR, we don’t just write a clinical evaluation for your medical devices – we provide sustainable support for your company, from defining and proving claims to PMCF strategies and beyond.

Unsere Vertragsformen Kontakt +49 451 808 503 60

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