MDR and Medical Devices with Indirect Clinical Benefits: Why a More Nuanced Assessment of Evidence Is Needed
The question of how to demonstrate the clinical benefit of a medical device may initially sound like a purely methodological issue. In fact, it determines which products remain available in Europe, how long approval procedures take, and how much effort manufacturers must invest in clinical evaluation. In the context of the ongoing MDR revision, this discussion is becoming significantly more intense, as not every product can be meaningfully evaluated using the same standards.
It is particularly challenging to evaluate products whose contribution to treatment success cannot be directly reflected in patient-centered clinical endpoints. These include surgical instruments, endoscopes, catheters, operating tables, and numerous other products that enable or support diagnostic or therapeutic procedures in the first place. For these products, an understanding of the evidence is needed that does justice to their actual mechanism of action.
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What does “indirect clinical benefit” mean?
Unlike drugs, many medical devices do not exert their effect through a direct therapeutic or diagnostic action on the patient. Their value lies in the safe, reliable, and efficient performance of medical procedures. A scalpel does not heal; it enables a precise incision. An endoscope does not treat; rather, it makes a diagnosis or a minimally invasive procedure possible in the first place.
The actual success of the treatment results from the interplay of several factors: the practitioner’s qualifications, the chosen treatment method, the patient’s individual situation, and the combination of various products and technologies. The product is a necessary component, but rarely the sole factor behind the result. This is precisely what makes it so difficult to measure its contribution in isolation.
Why Traditional Clinical Endpoints Have Their Limitations Here
Patient-reported clinical endpoints are considered the gold standard of evidence because they directly show whether a treatment is effective. However, they lose their significance when it comes to products with indirect benefits. If the success of the treatment depends largely on the surgical technique or the team’s experience, a clinical trial tends to evaluate the procedure rather than the product itself.
Furthermore, many of these technologies have been established for decades and have proven themselves millions of times over. In such cases, an additional clinical study would often merely confirm what has long been demonstrated in practice, without providing any real new insights regarding safety or performance. The effort involved would be disproportionate to the additional benefit for patient safety.
Alternative forms of evidence, which are often more meaningful
For many products with indirect clinical benefits, other data sources provide more direct information about their actual performance. Technical performance tests show whether a device meets the required specifications. Usability studies identify application errors before they become a risk. Risk analyses, as well as verification and validation data, systematically document that a product operates safely under real-world conditions.
In addition, there are findings from market surveillance. Observing a product over the course of years in thousands of applications provides reliable evidence of rare complications and long-term performance that a time-limited study could hardly capture. Real-world data and post-market clinical follow-up bridge the gap between the controlled study environment and everyday clinical practice and are therefore becoming increasingly important.
The Legal Dimension: The Principle of Proportionality
The debate is grounded not only in technical considerations but also in legal principles. Under the EU legal principle of proportionality, regulatory requirements must be suitable, necessary, and appropriate to achieve the intended level of protection. Applied to clinical evaluation, this means that additional data collection is justified only if it makes a relevant contribution to the assessment of safety and performance.
This raises a valid question: Do additional clinical trials for certain product groups actually yield new insights, or do alternative forms of evidence already fully meet the regulatory purpose? Where the latter is the case, it is difficult to justify a uniformly high standard for patient-reported outcomes without losing sight of the goal of high safety.
What the 2025/2026 MDR Revision Changes
On December 16, 2025, the European Commission presented its highly anticipated reform proposal for the MDR and IVDR (COM(2025) 1023). It addresses many of the issues described here. In the future, clinical requirements are to be designed in a more risk-based manner, and established technologies are to be considered in a more nuanced way. For mature products, the clinical evaluation should be able to rely more heavily on post-market surveillance and real-world data, so that additional prospective studies will be needed less frequently.
The range of recognized sources of evidence will also be expanded. In addition to traditional studies, bench tests, in silico models, computer modeling, and—under certain conditions—even non-peer-reviewed scientific literature will be given greater weight. In addition, reporting requirements will be simplified and the validity periods of certificates extended to facilitate risk-based, periodic reviews by the Notified Bodies.
However, the reform is not without controversy. Critics, including the TÜV Association, warn against lowering requirements for so-called “well-established technologies” too broadly. Without a clear definition, they argue, there is a risk that even individual high-risk products could be included and thus subject to overly lenient oversight. Differentiation must therefore not be confused with blanket relaxation of requirements. A precise distinction is crucial.
What This Means for Manufacturers, Notified Bodies, and Regulatory Authorities
For all stakeholders, the real challenge lies in further developing an understanding of evidence that does justice to the different operating principles of medical devices. Manufacturers should establish early on what level of clinical evidence is appropriate for their product and document alternative data sources in a structured and transparent manner. A well-thought-out regulatory strategy thus becomes a decisive competitive factor.
Notified bodies and regulatory authorities, in turn, are required to consistently evaluate this nuanced evidence. The goal is clearly defined: to ensure high safety standards while simultaneously creating a practical framework that promotes innovation and ensures the long-term availability of proven medical technologies in Europe. A differentiated assessment of evidence is not at odds with patient safety; rather, it is a prerequisite for its proportionate and effective implementation.
Especially during this transition phase, manufacturers benefit from experienced regulatory support that coordinates clinical evaluation, post-market surveillance, and conformity assessment, and that robustly prepares the rationale for the appropriate form of evidence in each case.