EU MDR Class I - Usability evidence needed?


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For a EU MDR Class I or Class Is device, is usability testing required? For example, manual surgical instrument for general use? I guess my question is, if testing is not always required, how do you decide when it is required?


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Usability study is not mandatory. The basis for determining the need for a usability study is risk analysis, meaning your need to identify user related risk and if the risk estimation is unacceptable you do a usability study to verify that the risk control is effective.

Class I devices are low risk by definition. It seems unlikely that you will need to do a usability study.



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one of our medical device is implentable class II (FDA) synthetic membrane for dental application. the use is very simple and staright forward with almost no training needed. my question is if usability study should be done in this case? I am not sure..


Starting to get Involved
Hi Humoor,

If your device is also considered implantable under the MDR definition, then the risk profile of the device is likely higher than the lower class devices discussed in replies above. As shimon indicated, the need for a usability study is unique per the device's intended use, performance characteristics, risk controls, etc. You claim that the use is very simple and straight forward... what is the basis for this / would that be true for any user? Can you use this as a justification for why no usability studies are conducted? You say *almost* no training required.. so it makes me think there is some room for error. How does the device compare to the market (i.e. - what is the State of the Art)? If your device is State of the Art, and its use is likely to be well understood by most clinicians, then I can see that a sound justification for not performing usability studies.
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