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 will find out why Claims are much more than mere advertising statements on how to correct them with measurable parameters and how the regulatory requirements of the MDR can be met. We show you where valid parameters come from, how they are evaluated and documented - and how they can derive well -founded 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. The focus is increasingly focused on claims , i.e. statements about performance, safety or benefit of a product. These claims are not just promise - they are regulatory verifiable and scientifically proven statements. The central yardstick for your credibility: measurable parameters .

A claim as "reduces wound healing by 30 %" initially looks impressive, but must also be verifiable. And this is exactly where the challenge - and chance - is for manufacturers.

2. State of the art - source for measurable parameters

The section "state of the art" (State of the Art, short: Sota ) is a fundamental part of any clinical evaluation according to MDR. It creates the medical-technical reference framework in which a medical device is assessed, thus forming the basis for the derivation of claims and its measurable parameters .

The aim is to analyze what is currently a medically and technologically established - based on the indication, application area, product class and functional alternatives. From this analysis:

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

derive.

2.1 What the state of the art must map

A complete Sota section describes:

2.1.1 The technical state of the art

• Which technologies, materials or designs are currently used?
• Which performance values ​​are the standard or "best practice"?
• Which standards, standards or regulatory requirements are established?

Example: For an imaging system, this would be, among other things, dissolution values, radiation dose, process times, digital interfaces or, if necessary, AI-based evaluation procedures.

2.1.2 The medical state of the art

focus here is on the clinical context of the product

• Indications : Which clinical pictures or clinical conditions are addressed with the product?
• Diagnostics and therapy methods : Which methods are currently considered the control standard for the treatment of these indications?
• Alternative applications : Are there products or procedures that perform similar tasks - even if they are structured or technically implemented?

Example: In the case of a wound therapy product, this would be common procedures such as hydroactive associations, vacuum therapy or enzymatic debridulation methods.

2.1.3. Data on comparable products

The consideration of existing medical devices is essential to identify relevant claims, target values ​​and evaluation criteria

• Which claims are made there?
• What data is available for their validation?
• Which parameters are used? - z. B. in the case of a wound therapy product, this would be the wound healing time, infection rates, technical measured values, etc.

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

2.2 Typical content and questions of the Sota

A well-founded Sota analysis answers the following questions:

Question	Goal
Which therapies are currently clinical standard in target indication?	Determination of the comparison basis
What are the alternatives to my product?	Identification of possible benchmarks
What is clinically proven with comparable products?	Orientation on validated parameters
What normative requirements must be considered?	Compliance with minimum technical standards

2.3 Sources for the state of the art

Several complementary sources should be taken into account for a valid and comprehensive SOTA analysis . This is the only way to create an objective and resilient image.

a) Scientific literature

• Original studies, clinical exams, systematic reviews
• Studies on effectiveness, security, use comparable technologies
• Meta -analyzes 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)
• Diagnostics, therapy and follow-up recommendations
• Inclusion of consensus papers and statements

Practical example: ESC guidelines for secondary prophylaxis are relevant for a product for stroke prophylaxis.

c) regulatory and technical norms

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

Important: Norms are not only important for technical evidence - they often also define measurement methods and requirements and therefore deliver measurable parameters!

d) Data on comparable medical devices

• Eudamed, FDA database, manufacturer's website
• Published admission or post-market studies
• Safety and performance parameters of comparable products

Don't forget: also search clinical studies of 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 the substantiation of innovations if they are documented in a comprehensible manner.

f) Other sources (in addition)

• Market analyzes, white paper
• Interviews with clinical experts
• Congress contributions and case reports

Caution: Marketing materials only as an orientation - no reliable source for regulatory statements.

3. Assessment of the parameters in the clinical evaluation

The clinical evaluation is the central instrument for assessing the safety and performance of a medical device within the meaning of the MDR. claims defined in advance are not only simple statements - they must be checked on the basis of objective, measurable parameters and scientifically validated. The evaluation of these parameters is therefore a critical step in order to achieve regulatory conformity and to prove the clinical relevance of the product features in a comprehensible manner.

The first step in this process is the definition of quantifiable criteria . Each claim must be clearly and objectively measurable. General or interpretable statements, such as "improved compatibility" or "high efficiency", are not sufficient. Instead, precise targets must be determined, on the basis of which the alleged effect or property of the product can be checked. This can be, for example, the healing time in days , the intensity of postoperative pain , measured by visual analog scale (VAS) , the integrity of tissue , determined by histological analyzes, or the infection rate compared to a control product. It is important that these parameters have a direct connection to the clinical application of the product and have a relevant impact on patient care or security.

This is followed by the selection of suitable evaluation methods . The decision for a specific method depends largely on the type of parameter and on the medical context. Controlled clinical studies (e.g. randomized controlled studies or post-market clinical follow-up, PMCF) are often used to validate the clinical benefits and performance under real conditions. Alternatively or in addition, preclinical studies , verification and validation tests as well as in-vitro or in-vivo models be used, especially if direct clinical examination is not (yet) possible. In this context, performance data is included, which, as described above, can also come from the technical state of the art.

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

As soon as valid data has been collected, the statistical evaluation and analysis . This serves to make the significance and relevance of the results understandable. Depending on the study design and data basis, various methods can be used-from average comparisons and standard deviations to confidence intervals to survival analyzes, such as those carried out Kaplan-Meier curves The aim of this analysis is not only to achieve statistical protection of the results, but also to communicate clinically relevant differences in an understandable and verifiable manner.

documentation is also an essential component of the evaluation . All steps - from the definition of the parameters to method selection to evaluation - must documented completely, transparently and comprehensibly . This documentation not only serves internal quality assurance, but is also a central element for communication with named areas and supervisory authorities. Without a complete and structured presentation of the derivation and checking of the claims, the clinical evaluation cannot be completed completely or regulatory.

4. Conclusion

With the introduction of the MDR, the understanding of product performance and security in the clinical evaluation has fundamentally changed. Central terms such as "clinical benefits", "clinical performance" and "security" are no longer vague terms, but clearly defined categories that must be documented by measurable parameters . These parameters support the claims of a product - i.e. the concrete statements with which manufacturers advertise, differentiate and position their solutions.

But a claim can only be resilient if it is based on objectifiable, quantifiable sizes ("measurable parameters") - and not on hypothetical promises. Statements such as "reduces postoperative pain", "shortens wound healing" or "improves diagnostics" are only durable in practice if they are supported by scientifically valid data. This data must come from a resilient methodological approach: from clinical studies, from verification and validation processes or by comparative analyzes with the state of the art.

The basis for this forms a structured and well-researched analysis of the State of the Art -i.e. the current medical-technical knowledge. This allows you to set realistic benchmarks, identify relevant target parameters and to understand which properties have comparable products. From this analysis, the claims are derived, which are then checked and documented as part of the clinical evaluation.

systematics and traceability is particularly important : every step - from the formulation of the claim to the selection of the evaluation method to data analysis - must be documented and regulatory. This is the only way to check whether a product actually does what it promises. At the same time, this creates the prerequisite for credible communication towards doctors, nursing staff and patients.

In addition, the clean wording and validation of claims also has strategic added value : it creates differentiation in the market, makes market access easier in other countries and strengthens confidence in the brand. Products whose statements are scientifically proven and regularly sustainable enjoy a significantly higher acceptance in everyday clinical life - and ultimately contribute to better patient care.

It is therefore clear that the quality of the claims and their measurable parameters decides on the regulatory approval, the clinical relevance and the commercial success of a medical device. A strong product needs strong statements - but these have to be proven, not just claimed.

In order to achieve this, an interdisciplinary approach required: regulatory affairs, clinical research, product development and quality assurance must work closely together. This is the only way to achieve the necessary depth and quality in the evaluation. Anyone who takes this into account from the start not only minimizes the risk of regulatory queries, but also increases the efficiency of the approval process and creates a sustainable competitive advantage.

The investment in a well-founded Claim strategy and the clean 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 is exactly where you need you: at the interface between regulatory requirements and scientific evidence. We support you in:

• The definition of realistic, regulatory resilient claims
• The research and derivation of suitable measurable parameters
• The implementation of benchmark analyzes
• The clinical evaluation of your products according to MDR
• The creation of resilient documentation for named areas

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