Usability engineering – regulatory requirements and IEC 62366

Usability engineering has long been used in a wide variety of industries. A good concept of usability is important to ensure sufficient safety. Thus, usability engineering is also an essential part of the regulations and requirements for medical devices. According to IEC 62366, usability is the “property of the user-product interface that includes effectiveness, efficiency, ease of learning and satisfaction of the user.” Thus, usability is not defined by design, but focuses on logical and effective usability by the user.

Why good usability is so important for your medical devices

Good usability ensures that your medical device works as intended or as expected. This prevents errors that could potentially endanger the safety of patients. According to an article in MTD, experts estimate that there are about 17,000 application errors with fatal consequences in German hospitals each year that could have been avoided. Two-thirds of these are due to operating errors and only one-third to product defects. To ensure that medical devices are easier and safer to use, both hospitals and testing bodies are now required to increasingly take the requirements of IEC 62366 into account in their audits. With excellent usability, you not only meet the requirements of the notified bodies, but also ensure a high level of acceptance of your medical device among your target group.

Usability Engineering: Regulatory Framework

The legal framework for usability is defined on the basis of different legislations (e.g. the MDR ). This sets out certain requirements for efficient usability of medical devices.

The MDR attaches great importance to usability and stipulates in its basic requirements that manufacturers must minimise risks that could arise from inadequate usability. This is to be achieved on the one hand by the ergonomic features of the medical device and the environmental conditions in which it is used. In addition, the technical knowledge, experience and physical requirements of the persons who will later use the medical device should also be taken into account. For example, usability must be adapted accordingly if your product is to be used not only by specialists but also by laypersons. This makes it clear that usability must always be understood in the context of the actual purpose of the product and the people who use it. Good usability can also be ensured, according to the MDR, by accurate technical documentation that includes the results of product verification and validation related to usability. In addition, you should also collect and evaluate user feedback about use problems as part of post-market clinical follow-up and post-market surveillance.

The FDA provides a guidance document entitled “Applying Human Factors and Usability Engineering to Optimize Medical Device Design”. This “textbook” is not a standard, but it includes some requirements and shows which methods you need to use to analyse risks. It also describes how to conduct and document usability tests. The FDA is guided by IEC 62366 and refers to its regulations.

The IEC 62366 standard

The various institutions in the respective countries and continents have different regulatory requirements for good usability of medical devices. However, IEC 62366 forms an overlap here and is recognised by both the MDR and the FDA. The focus of IEC 62366 is without question on risk management. The aim is to minimise the risk of poor usability. However, a higher market success of the products or a more efficient development, also goals that can be achieved through optimised usability engineering, are not considered within the framework of IEC 62366.

For an optimal minimisation of risk, IEC 62366 primarily describes a development process that is oriented towards usability (“usability engineering process”). In order to comply with this process, you as manufacturers are obliged to

describe the specification of its use (specifically, this means explaining the context of use, the users and patients, and the physical principle of the medical device).
Specify the usability of their medical devices
Verify and validate the usability

IEC 62366 sets certain requirements for each of these process steps. For example, during the validation of a medical device, the users are observed in a realistic usage environment in which they use the medical device for typical or safety-critical tasks.

However, IEC 62366 not only obliges you to carry out the respective process steps, but also to document them in a corresponding usability engineering file. For this purpose, the BAYOOSOFT Risk Manager has integrated the complete process of usability engineering and guides you step by step to the usability engineering file. This makes documentation much easier for you.

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