It has not been proven: How measurable parameters support their claims in the clinical evaluation - and what they need to know

In this blog post, you'll learn why claims are far more than mere advertising statements, how to correctly substantiate them with measurable parameters, and how to meet the regulatory requirements of the MDR. We'll show you where valid parameters come from, how they are evaluated and documented – and how you can derive sound benchmarks from the state of the art.

Abbreviations

MDR	Medical Device Regulation (EU Ordinance 2017/745)
Sota	State of the Art (state of the art)
CRP	C-reactive protein
VAS	Visual Analog Scale
RCT	Randomized Controlled Trial
Pmcf	Post-market clinical follow-up
KPI	Key Performance Indicator

Underlying regulations

EU Regulation 2017/745 (MDR)

1 Introduction

The development and approval of a medical device in Europe is a complex, highly regulated process. Claims —statements about a product's performance, safety, or benefits—are increasingly taking center stage. These claims are not merely promises; they are statements that are subject to regulatory review and scientific substantiation. The key criterion for their credibility: measurable parameters .

A claim like "Reduces wound healing time by 30%" initially sounds impressive, but it also needs to be substantiated. And that's precisely where the challenge – and opportunity – lies for manufacturers.

2. State of the art – Source of measurable parameters

The "State of the Art" ( SotA ) section is a fundamental component of every clinical evaluation according to the MDR. It establishes the medical-technical reference framework within which a medical device is assessed and thus forms the basis for deriving claims and their measurable parameters .

The aim is to analyze what is currently considered medically and technologically established – with regard to indication, area of ​​application, product class, and functional alternatives. This analysis will yield:

• the expectations for a product ,
• the relevant performance and safety indicators
• as well as benchmarks for measurable parameters

derive.

2.1 What the state of the art must reflect

A complete SotA section describes:

2.1.1 The state of the art

• What technologies, materials, or designs are currently being used?
• What performance metrics are considered standard or "best practice"?
• What norms, standards, or regulatory requirements are established?

Example: For an imaging system, this would include, among other things, resolution values, radiation dose, processing times, digital interfaces or possibly AI-supported evaluation methods.

2.1.2 The state of the art in medicine

focus here is on the clinical context of the product

• Indications : Which diseases or clinical conditions are addressed by the product?
• Diagnostic and therapeutic methods : Which procedures are currently considered the standard of care for these indications?
• Alternative applications : Are there products or processes that fulfill similar tasks – even if they are structured or technically implemented differently?

Example: For a wound therapy product, these would be common procedures such as hydroactive dressings, negative pressure wound therapy, or enzymatic debridement methods.

2.1.3. Data on comparable products

Examining existing medical devices is essential to identify relevant claims, target values, and evaluation criteria

• What claims are being made there?
• What data is available to validate them?
• Which parameters are used? – e.g., for a wound therapy product, these would potentially be wound healing time, infection rates, technical measurements, etc.

This information is necessary to classify one's own product approach as either "state of the art" or "innovative and superior".

2.2 Typical content and questions of the SotA

A thorough SotA analysis answers, among other things, the following questions:

Question	Goal
Which therapies are currently the clinical standard for the target indication?	Determination of the basis of comparison
What alternatives are there to my product?	Identification of potential benchmarks
What has been clinically proven for comparable products?	Orientation towards validated parameters
What regulatory requirements must be observed?	Compliance with minimum technical standards

2.3 Sources for the state of the art

For a valid and comprehensive SotA analysis, several complementary sources be considered. Only in this way can an objective and reliable picture be created.

a) Scientific literature

• Original studies, clinical trials, systematic reviews
• Studies on the effectiveness, safety, and benefits of comparable technologies
• Meta-analyses or evidence-based recommendations

Tip: Use targeted databases such as PubMed, Embase or Cochrane Library.

b) Medical guidelines

• National and international recommendations (e.g. AWMF, NICE, ESMO, EORTC)
• Diagnostic, therapeutic and follow-up recommendations
• Inclusion of consensus papers and statements

Practical example: For a product for stroke prevention, ESC guidelines on secondary prevention are relevant.

c) Regulatory and technical standards

• ISO, IEC, DIN, CEN standards
• Requirements for safety, functionality, software, biocompatibility

Important: Standards are not only important for technical verification – they often also define measurement methods and requirements, thus providing measurable parameters!

d) Data on comparable medical devices

• EUDAMED, FDA database, manufacturer websites
• Published registration or post-market studies
• Safety and performance parameters of comparable products

Don't forget: Also search clinical trials from competitors on clinicaltrials.gov or EU-CTR!

e) Own data sources

• Preclinical test reports
• Technical Performance Studies
• Validation and verification data
• Results of early-use projects

Note: This data is particularly valuable for substantiating innovations, provided it is documented in a traceable manner.

f) Further sources (supplementary)

• Market analyses, white papers
• Interviews with clinical experts
• Conference papers and case reports

Caution: Marketing materials are for guidance only – not a reliable source for regulatory statements.

3. Evaluation of parameters in the clinical evaluation

claims defined beforehand are not simply statements – they must be verified based on objective, measurable parameters and scientifically validated. The evaluation of these parameters is therefore a critical step in achieving regulatory compliance and demonstrably proving the clinical relevance of the product characteristics.

The first step in this process is defining quantifiable criteria . Every claim must be unambiguous and objectively measurable. General or interpretable statements, such as "improved tolerability" or "high efficacy," are insufficient. Instead, precise target variables must be determined against which the claimed effect or property of the product can be verified. These could include, for example, the healing time in days , the intensity of postoperative pain measured using a Visual Analog Scale (VAS) , tissue integrity determined by histological analysis, or the infection rate compared to a control product. It is crucial that these parameters have a direct bearing on the clinical application of the product and a relevant impact on patient care or safety.

The next step is selecting appropriate evaluation methods . The choice of a specific method depends largely on the type of parameter and the medical context. Controlled clinical trials (e.g., randomized controlled trials or post-market clinical follow-up, PMCF) are frequently used to validate clinical benefit and performance under real-world conditions. Alternatively or additionally, preclinical studies , verification and validation tests , and in vitro or in vivo models can be used, particularly if direct clinical investigation is not (yet) possible. In this context, performance data are also considered, which, as described above, can also be derived from state-of-the-art technology.

In some cases, a comparative analysis with existing literature or existing market products may also be sufficient, especially if the product corresponds to established solutions in its function or technology.

Once valid data have been collected, statistical evaluation and analysis . This serves to demonstrate the significance and relevance of the results. Depending on the study design and data basis, various methods can be used – from comparisons of means and standard deviations to confidence intervals and survival analyses, such as those performed with Kaplan-Meier curves . The aim of this analysis is not only to achieve statistical validation of the results but also to communicate clinically relevant differences in a clear and verifiable manner.

Documentation is an essential component of the assessment . All steps – from defining the parameters and selecting the methods to the evaluation – must fully, transparently, and comprehensibly documented . This documentation not only serves internal quality assurance but is also a key element for communication with notified bodies and regulatory authorities. Without a complete and structured presentation of the derivation and verification of the claims, the clinical assessment cannot be concluded fully or in a regulatory-acceptable manner.

4. Conclusion

With the introduction of the MDR, the understanding of product performance and safety in clinical evaluation has fundamentally changed. Key terms such as "clinical benefit," "clinical performance," and "safety" are no longer vague concepts, but clearly defined categories that must be substantiated by measurable parameters . These parameters, in turn, support claims —that is, the specific statements manufacturers use to promote, differentiate, and position their solutions within the regulatory framework.

However, a claim is only valid if it is based on objective, quantifiable factors ("measurable parameters") – and not on hypothetical promises. Statements such as "reduces postoperative pain," "shortens wound healing," or "improves diagnostics" are only tenable in practice if they are supported by scientifically valid data. This data, in turn, must originate from a robust methodological approach: from clinical studies, verification and validation processes, or comparative analyses with the state of the art.

The foundation for this is a structured and well-researched analysis of the state of the art – that is, the current state of medical-technical knowledge. This allows for the establishment of realistic benchmarks, the identification of relevant target parameters, and an understanding of the characteristics of comparable products. Claims are derived from this analysis and are then reviewed and documented as part of the clinical evaluation.

Systematic and traceable processes are particularly important : Every step – from formulating the claim and selecting the assessment method to data analysis – must be clearly documented and regulatory-compliant. Only in this way can notified bodies or regulatory authorities verify whether a product actually delivers on its promises. At the same time, this creates the foundation for credible communication with doctors, nurses, and patients.

Furthermore, the clear formulation and validation of claims also offers strategic added value : it creates differentiation in the market, facilitates market access in other countries, and strengthens brand trust. Products whose claims are scientifically substantiated and regulatory-compliant enjoy significantly higher acceptance in everyday clinical practice – and ultimately contribute to better patient care.

It is therefore clear: The quality of the claims and their measurable parameters determines the regulatory approval, clinical relevance, and commercial success of a medical device. A strong product needs strong claims – but these must be proven, not just asserted.

To achieve this, an interdisciplinary approach required: Regulatory Affairs, clinical research, product development, and quality assurance must work closely together. Only in this way can the necessary depth and quality of the assessment be achieved. Those who consider this from the outset not only minimize the risk of regulatory queries but also increase the efficiency of the approval process and create a sustainable competitive advantage.

Investing in a sound claim strategy and the clear definition of measurable parameters is therefore not a bureaucratic effort, but an investment in the future viability of your product .

5. How we can help you

Our expertise lies precisely where you need it: at the interface between regulatory requirements and scientific evidence. We support you with:

• The definition of realistic, regulatory-sound claims
• The research and derivation of suitable measurable parameters
• Conducting benchmark analyses
• Clinical evaluation of your products according to MDR
• The creation of reliable documentation for notified bodies

Would you like to know more? Contact us for a free initial talk !