UK regulatory authority the Medicines and Health products Regulatory Agency (MHRA) has started to develop guidance on human factors for medical devices. We are curious to see how the guidance will fit with the FDA’s Guidance documents, published over the past few years.

The Agency has confirmed that the planned guidance will cover several topics;

  • Pre-market regulatory framework (including end users),
  • Post-market surveillance regulatory framework,
  • Standards,
  • Simulation / Usablity.

When draft guidance is published, we’ll be updating you on the content and implications for both medical devices and combination products.  Read on to understand more about what led to the announcement.

Origins of the MHRA Human Factors guidance

Development of the guidance is being managed by a task group set up by MHRA, with the involvement of notified bodies, academia, NICE, trade bodies and professional associations. The task group held its second meeting recently. At the meeting, Dr Brian Edwards of the Clinical Human Factors Group emphasised the need to consider the requirements of combination products, saying:

“It’s important to work together in particular areas where we have overlapping interests such as drug/ device combinations.”

Understanding Human Factors in medical device design

The task group was born out of a wider meeting held on 27th February 2015. The February meeting involved a wide cross-section of interested parties and considered how we can build better understandings of human factors into the design, regulation and use of medical devices, to promote patient safety.

The keynote presentation at this important event was delivered by Dr Ann Blandford, who we’ve had the pleasure of discussing human factors challenges with on several occasions over the past couple of years. Here’s what Dr Blandford had to say about the importance of human factors, at that event:

A patient perspective of the value of involving end users in device development was eloquently described by Fiona Loud of the British Kidney Patient Association:

Next steps for MHRA guidance on Human Factors

The task group will have a further two meetings to develop the draft guidance.

MHRA plan to follow up on the work already done, by sharing the draft guidance with a wider group in the Spring of 2016.

You might choose to check back here, or subscribe to our blog, to be among the first to hear about the content of the draft guidance when it is shared.