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MDR, FDA and IEC on Usability Engineering

In the MDR, the word usability or usability in the German form occurs only twice. However, there are requirements on the subject of usability in many different places in the guideline. At at least 10 places requirements are made to the product and the manufacturer, which can be fulfilled only with a useful Usability engineering process. These include, among others:

    • The reduction of risks based on ergonomic features of the product
    • The consideration of the user’s skills, abilities, etc.
    • The safe use of the product by non-professionals (in case non-professionals are a user group)
    • The creation of instructions for use, appropriate for the user

The MDR thereby equates an application error, if necessary, with a product failure, if it could have been prevented by an appropriate process.
The reference to the area of usability is clear here.

.The Food and Drug Administration (FDA) even goes one step further and requires a clear usability engineering or human factors engineering process that ensures good operable and safe products and its documentation.
For this, the FDA even issues a guidance document to assist manufacturers in writing the documentation.

The relevant standard in the field is the IEC 62366-1:2015: it deals with the application of usability engineering to medical devices.
In the standard, the establishment and implementation of a usability engineering process is required, which is accompanied by proven appropriate personnel. This includes coordination with risk management, derivation of relevant test cases, and developmental (formative) and final (summative) testing of the medical device and acceptance criteria.

All steps of the usability engineering process are documented concurrently in the usability engineering file, which subsequently forms the foundation for the assessment of the process by the Notified Body.

In all of these standards and guidelines, the focus is on ensuring that the use of the product does not pose a risk to patients, users, or third parties through an appropriate usability engineering process.


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