The following article was first published on June 18, 2026, on Medtec Online, a website supported by Bundesministerium für Forschung, Technologie und Raumfahrt (The Federal Ministry of Research, Technology, and Space):
https://medteconline.de/info/magazine/blog/strong-mdr-reform-im-fokus-usability-engineering-strong-7?ref=/info/magazine
Usability Data as Clinical Evidence – Regulatory Evolution or Overestimated Hope?
On May 25, 2017, the MDR and the IVDR entered into force. The objective of both regulations was to ensure the safety of medical devices and IVDs and thereby enhance patient safety. In addition, the same standards were to apply across Europe, and transparency regarding incidents and product traceability were to be improved. A longer – and subsequently extended – transition period was intended to allow manufacturers to implement processes at a reasonable pace after the regulations took effect.
A joint industry survey conducted in October 2025 by the German Medical Technology Association (Bundesverband der Medizintechnologie e.V.), Medical Mountains, SPECTARIS, and the German Diagnostics Industry Association paints a significantly less positive picture of the actual results nearly ten years after the MDR and IVDR came into effect. Fifty-three percent of the companies surveyed stated that they had reduced their own research and development activities over the past five years due to the MDR/IVDR. Over 40 percent of the companies reported that newly developed innovations were not launched in the EU but were instead approved in other markets. Furthermore, the MDR/IVDR did not fully achieve harmonization of regulations across EU countries: 38 percent of the companies surveyed stated that they had not launched products throughout the entire EU, due to national laws and regulations. So-called orphan devices have been hit particularly hard by the additional regulatory burdens that manufacturers have faced since the MDR/IVDR took effect. Sixty-four percent of manufacturers of orphan devices reported that they have discontinued products since the regulations took effect. This creates a direct gap in care for people affected by rare diseases, which is difficult to fill economically under the current regulations.
This survey – along with many others – and the internal evaluation of the regulations prompted the European Commission to present proposal COM(2025) 1023 for the revision of the MDR and IVDR at the end of 2025. The explicit aim of the proposal is to simplify regulatory requirements and reduce the identified “unnecessary burdens for manufacturers” without compromising “the high level of public health and patient safety” (COM(2025) 1023, Recital 3, p. 22).
The proposed reform thus marks a potential paradigm shift within European medical device regulation: away from an evidence-based approach focused almost exclusively on documentation and clinical studies, and toward more risk-based, proportionate, and innovation-friendly assessment approaches.
It is precisely in this context that a question that has thus far been considered rather marginal is gaining increasing importance: Can usability, human factors, and real-world usage data be utilized more extensively in the future to draw conclusions about the clinical safety and performance of medical devices?
The MDR’s Regulatory Approach to Usability Engineering to Date
Although the MDR has significantly strengthened the role of usability engineering as a fundamental part of medical device development compared to the previously applicable regulations, the core regulatory focus of usability and human factors engineering has remained limited to risk management. The normative framework for this is provided by the IEC 62366-1 in conjunction with the ISO 14971 .
In its current form, the existing regulatory framework fails to recognize the potential of usability engineering to contribute not only to safety but also to the success of the product in everyday (clinical) use. At this time, the use of usability data as standalone clinical evidence is generally not provided for and is therefore not possible. In current practice, therefore, summative usability studies, use-error analyses, and workflow studies primarily serve the following purposes:
- To identify misuse early on,
- To assess existing residual risks,
- adapt the user manuals or
- to develop training measures.
This is how the EU Commission’s MDR reform proposal shifts the evidence-based approach
However, the proposed amendment suggests a significantly more flexible approach to forms of evidence. Recital 9 is particularly relevant, in which the Commission states: “Clinical data are an important source of information for demonstrating the safety and performance of a device. However, the process of generating clinical data is often lengthy and costly.” The following statement also points in this direction: “The definition of clinical data should be broadened to enable the use of data generated through studies on the device concerned that are published in scientific literature, but not necessarily peer-reviewed.” (COM(2025) 1023, Recital 9, p. 23). Although usability data is not directly mentioned here and the word “usability” does not appear in any form in the new proposal, this wording signals a potentially significant regulatory shift. The Commission is thus explicitly signaling that clinical evidence should be interpreted more broadly in the future and need not originate exclusively from traditional clinical studies. However, the proposal also makes it clear that this adjustment and expanded assessment logic are intended primarily for “well-established technology devices” and lower-risk medical devices.
This is precisely where regulatory opportunities are emerging for the increased use of:
- usability data,
- real-world usage data,
- simulated application scenarios,
- digital usage analytics,
- workflow analyses,
- post-market data on use errors.
Why Usability Is Clinically Relevant
Usability is playing an increasingly important role, as evidenced by the fact that many safety-critical incidents today are not primarily caused by technical defects, but rather by:
- operational error,
- cognitive overload,
- poor user interface,
- incorrect interpretation,
- alarm Fatigue,
- complex operating logic.
The shift of medical devices from clinical to home settings via so-called home care devices also suggests that good usability will become increasingly important in the future for preventing use errors. The range of products affected by this is extensive, spanning from simple apps – with or without AI support – to standalone diagnostic solutions that empower users to perform tasks that were previously clearly the responsibility of healthcare professionals. The quality of diagnosis and treatment is thus even more directly linked than before to users’ ability to use medical devices correctly – and this without the typical safety net of extensive training or prior clinical knowledge.
It follows that, for products with the same mechanism of action, evidence of improved usability compared to existing products may indicate improved quality of care and – depending on the product – better adherence to certain treatments. Through comparative studies on usability, benefits for patient care can thus be identified that stem from the safe and easier use of the products. These types of benefits are already being claimed in some cases as so-called “indirect clinical benefit claims.” The aim here is to focus on benefits for patients and healthcare providers that arise not from clinical trials, but from the use of the products themselves. The proposed MDR reform opens the door to discussions on how the tangible benefits for patients and users in the everyday use of low-risk and well-established products can be appropriately reflected in regulatory frameworks.
Conclusion
The Commission’s proposal COM(2025) 1023 points to a significant shift in European medical device regulation. The proposed changes promote a more risk-based, flexible, and proportionate evidence model. In particular, the explicit call to “broaden” the definition of clinical data could have significant long-term implications for the regulatory significance of usability and human factors data.
It seems realistic to expect greater regulatory use of such data, particularly for:
- established technologies,
- class IIa products,
- digital medical devices,
- home-use systems,
- incremental software changes,
- products with an extensive post-market history.
Despite this possible development, however, it would be a mistake to interpret the reform as a regulatory shift away from clinical evidence. Nowhere in the Commission’s proposal is there an explicit statement that usability data is intended to replace traditional clinical evidence. Even in the future, Notified Bodies are expected to continue to impose high requirements for evidence of clinical safety and performance—particularly in the following areas:
- high-risk medical devices
- implantable systems
- innovative technologies
- AI systems that make autonomous decisions
- products with a direct therapeutic effect.
For now, human factors data will be relevant as a supplement, but will hardly be sufficient to replace traditional clinical evidence. Furthermore, it remains to be seen how consistently Notified Bodies will actually interpret the new leeway they have been given. Even today, there is considerable heterogeneity within Europe in the assessment of clinical evidence and the interpretation of submitted usability data. Without additional MDCG guidance or harmonized assessment criteria, practical implementation could therefore vary significantly.
In addition, this option also creates work for all usability and human factors experts. The use of usability data as an alternative to clinical evidence requires high data quality, which is currently only partially guaranteed. This is particularly evident with usage data collected in the field, which often
- incomplete,
- context-dependent,
- difficult to compare,
- statistically limited,
- may be distorted.
The development of more reliable methods and their rigorous application will play a key role in determining just how valuable usability data can truly become as a substitute for clinical evidence in the future. The real challenge in the future will therefore be less about generating more usability data and more about demonstrating, in a manner that stands up to regulatory scrutiny, when and to what extent good usability can actually be interpreted as clinically relevant evidence. Whether this succeeds – and actually reduces the burden on manufacturers, as originally planned with the revision – will depend largely on whether all stakeholders can agree on a suitable set of methods. This set of methods must capture usability data that measures actual added value without driving up the cost. From the author’s perspective, a lively discussion within the usability industry – but also with all other stakeholders – is desirable regarding what these methods might look like in order to lead to simpler demonstration of clinical evidence. This topic remains fascinating!
