We now have official guidance for Human Factors and Usability Engineering in a member state of the EU.
19th September 2017 saw publication of official guidance from MHRA (the UK medicines and medical devices regulator) for Human Factors and Usability Engineering for medical devices and drug-device combination products. You may recall that the agency published a draft document for consultation in mid 2016. The final document extends to 47 pages and includes many changes as a result of consultation responses.
While of detailed interest to people working within human factors, everyone else probably wants to find out “what does it mean for me?”
So, here are 15 things you need to know about the MHRA guidance:
MHRA’s newly released final guidance emphasises its applicability to all classes of medical devices and device-drug combination products, there’s absolutely no avoiding usability engineering.
Content of the guidance appears closely aligned with FDA guidance and international standards, with some useful additional information to that discussed by FDA.
MHRA provide a great tool for anyone making the case for usability activities within their organisation; the guidance spells out exactly the essential requirements in the Medical Devices Regulation (MDR) and In-Vitro Diagnostic medical devices Regulation (IVDR) that mandate usability activities, along with a helpful annex mapping the MDD and IVD to the new regulations.
These breadcrumbs will also help manufacturers who are working to prepare their devices for the end of the MDR and IVDR transition periods.
Clearing the once muddy waters surrounding drug-device combination products, MHRA establishes that the Essential Requirements enshrined in the MDR and IVDR are equally applicable to the device components of drug-device combination products.
The document provides a helpful compendium of regulations, standards and guidances that should be referred to for development. The information can be seen as a signpost for those just venturing in to this arena, and serves as a reminder for the seasoned manufacturer.
MHRA appear to have adopted a more realistic approach to the guidance on risk analysis, pulling back from the previous stance of expecting documentation of all possible use errors to a more realistic approach of capturing “reasonably foreseeable” use errors. This sits well with FDA expectations. A gift for usability professionals battling to influence sensible and design oriented risk management, MHRA have included an expectation of a rationale for the prioritisation of risk mitigations, often overlooked by development teams.
Thankfully, the finalised guidance requires the development of a user interface specification and a usability plan at an early stage in development, aiding the inclusion of usability activities within project timelines, resourcing and budgeting, rather than as a last minute “add-on”.
The value of formative usability studies is enhanced by closing the loop from risk analysis informing formative study design through to feeding back into the risk analysis the results of a formative test (unforeseen use errors, occurrence levels, etc.).
Rightly, there’s now heavy emphasis on the ethics dimension of formative testing and manufacturers responsibility to ensure appropriate ethical consideration is given to the design and execution of formative and summative studies.
Summative testing (called validation by FDA) now explicitly includes training that may be needed, and sets the realistic expectation for inclusion of users who are unfamiliar with the particular device.
The HF Summary Report, whilst a very useful document to describe the usability journey, does not achieve all FDA expectations (in particular a greater focus on risk), so manufacturers will need to determine how best to fulfil both sets of guidance, if they intend to market their device(s) in both the EU and US.
Helpfully, the section on Post Market Surveillance identifies some potential data sources, that will help manufacturers get more out of these activities for both existing products and future development projects.
Guidance is now given about what to do for older products, of particular relevance as their manufacturers gear up to ensuring compliance with the MDR in the near future.
The whole topic of simulation, which previously gave rise to concern amongst manufacturers, has now been removed from the guidance. Instead, the reader is pointed towards information covered in ISO 62366 (parts 1 and 2).
With regard to drug/device combination products, the guidance points to changes in the MDR that require an assessment of device components with the Essential Requirements (including those related to human factors / usability). Helpfully, the MHRA document also references EU guidance relating to drug-delivery devices and specific products.
Now that you’ve read all 15 things, you may find it helpful to talk with someone about what you’ll be doing differently for your upcoming projects, and existing products.
Pick up the phone today, or write an email to our team right now.