New MHRA guidance: designing medical devices that lower chances of human error

18 October, 2017

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on taking human factors and usability engineering into account when designing medical devices. Take, for example, devices that automatically administer drugs: the way that these machines are designed may increase or decrease the likelihood of delayed delivery of medication or overdose as a result of human use. The interactions between person and machine are known as “human factors”.

The guidance is helpful for both manufacturers and notified bodies. It applies to the design of future products and changes in user interfaces of existing products.

The guidance refers to the essential requirements under the three existing EU Medical Device Directives (which have been incorporated into UK legislation) and the guidance specifically states that it will be equally useful in supporting demonstration of compliance with the new EU Medical Device Regulation (applying from May 2020) and In Vitro Diagnostic Device Regulation (applying from May 2022). The USA Food and Drug Administration already has extensive information and guidance on human factors related to medical devices and this new MHRA guidance is intended to be consistent with the FDA guidance.

The guidance clarifies and focuses on two things:

  1. That usability engineering is an iterative process, involving design, testing and validation of design stages. This extends to after the product is on the market because it may become apparent that, on using the device in clinical practice, the design requires further improvement.
  2. Ways in which human factors can be applied to medical devices, so that they are designed and optimised for use by intended users, in the environment in which they are likely to be used, for safe and effective performance.

Click here to access the MHRA’s guidance in full.