MHRA releases Guidance on Human Factors and Usability Engineering

In the beginning of June, MHRA has release its guidance Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products. It is meant to help Medical Device manufacturers in the areas of human factors and usability engineering and clarifies the expectations of the notified bodies around compliance with the EU medical device legislation.


The content is to a large extent a reiteration of IEC 62366-1:2015. In any case, this is yet another indication of the increased focus involved agencies place on Human Factors and Usability Engineering.

Should you be interested in finding our more about how Aligned Elements implements IEC 62366-1:2015, click here.

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