How eye tracking validates medical device safety and performance

MedTech companies developing regulated medical devices face mounting pressure from more stringent clinical evidence requirements. This pressure is not limited to one market. Regulatory authorities increasingly expect proof of safe and effective use across regions. These expectations are reflected in frameworks such as the EU MDR (EU 2017/745) and FDA guidance on human factors and usability engineering. 

Defining safety and performance in practice 

MedTech companies need to demonstrate that their products are safe to use and perform as intended, supported by documented evidence of use in real-world conditions. In a regulatory context, safety extends beyond mechanical or technical failures. It includes use-related risks and foreseeable misuse, while performance includes correct interpretation and interaction with the device. 

As stated in the EU Medical Device Regulation: 

Are there risks of misinterpreting the device used to diagnose a patient?

Is there a possibility of missing crucial information in the software used to interpret symptoms?

Is the medical technology designed so that, under stressful conditions, it can be used effectively and intuitively?

Clinical evaluation activities are expected to address these questions to comply with global medical device regulations.

Challenge of showing real-world use objectively

One of the most persistent challenges is demonstrating real-world use in a credible, objective manner. Regardless of which regulatory authority reviews the submission, MedTech companies must be able to show how use-related risks are identified, assessed, and mitigated. 

Common challenges include overreliance on subjective user feedback, limited visibility into how users interact with interfaces and instructions, and difficulty linking observed behavior to safety and performance claims. 

Regulatory authorities explicitly expect manufacturers to validate that devices can be used safely and effectively, not merely to design them with those goals in mind. 

As stated in FDA guidance on human factors and usability engineering: 

What eye tracking measures and why it matters 

Eye tracking is a sensor technology that measures where users look, for how long, and in what order. It provides insight into visual attention and information processing during task execution. Tobii offers screen-based and wearable eye trackers to help companies understand focus and awareness and to provide new perspectives on
training, skills assessment, usability testing, and more. 

From observation to quantifiable evidence 

Eye tracking enables MedTech companies to objectively assess potential risks and evaluate how medical devices are used in their intended environments. The resulting data is quantifiable and reproducible, offering insight into visual attention, which is directly tied to understanding, decision-making, and task execution. 

Moving beyond subjective usability assessments 

This makes eye tracking a suitable method for evaluating medical devices, not only from a user experience perspective but also as part of regulatory evidence generation. With eye tracking, MedTech companies can demonstrate that critical information is noticed and processed, identify use errors and latent risks early, and support claims of safe and effective use. This data can strengthen clinical evaluation reports, usability engineering documentation, and design validation activities. 

What regulatory authorities expect to see 

Regulatory authorities look for several key elements when assessing whether a medical device meets safety and performance requirements.

These include:

• Traceability of identified risks

• Supporting evidence

• Conclusions; methodological rigor supported by documented protocols

• A clear linkage between observed user behavior and safety or performance outcomes.

Because eye tracking data are objective and quantifiable, they can enhance the clarity and credibility of these claims during regulatory review. 

Turning evidence into confidence and advantage 

Understanding real user behavior improves regulatory compliance and product quality and can ultimately become a competitive advantage. Supporting safety and performance claims with strong, objective evidence reduces regulatory risk across markets and contributes to better-designed devices and improved patient outcomes.