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Do I have to do usability engineering?

Even though usability engineering has been common practice in other industries for a long time, the question keeps coming up: do I have to do usability engineering as a medical device manufacturer, or is it voluntary?


The answer to this question has changed significantly in recent times. A look at the European Product Safety Directive from 2001 still shows no explicit mention of the term usability or fitness for use.

But even then, this was indirectly required several times: The manufacturer must take into account the “foreseeable use” for products or provide comprehensible instructions for use.
At the latest with the harmonization of IEC 62366:2008 with the Medical Device Directive at the end of 2008, it became clear that the usability of medical devices was becoming an increasingly important part of the development and approval of a medical device.

From May 26, 2021, the new MDR (Medical Device Directive) will finally apply. This contains for the first time already in the directive the term usability and thus recognizes usability as a component of product safety. With the implementing decision on the new Medical Devices Directive, although the 2366:2008 can no longer be referred to,

Experts, however, expect the harmonization of 62366-1:2017 in a timely manner, which will impose even more stringent usability engineering requirements for medical devices.

So the answer is: Yes, if your product is a “washable” medical device with approval, then you cannot avoid usability engineering and testing.

By the way, this already applies from class 1, even if no notified body is required for approval here, but you can declare conformity yourself.

The usability engineering file is and remains part of the required documentation. But as always in the field of medical devices, the focus of usability engineering, from a purely legal point of view, is clearly on demonstrating safety in the use of the product, and less (or not at all) on delighting users.

Make approval easier and less stressful? We will be happy to advise you or, if you wish, take over the entire usability engineering process: contact us now.


The regulatory landscape: MDR, FDA and IEC

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