It is expected the UK and the EU will not agree to retain the regulation of medical devices within a common EU regulatory framework. This means that from January 1st 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will become the standalone medicines and medical devices regulator for the UK.
With regards to the regulation of medical devices, the UK Government is planning a new piece of legislation called the Medicines and Medical Devices Bill. The MHRA has already stated in its most recent advice that it intends to “take into consideration international standards and global harmonisation” in the development of any future system of medical device regulation. And that they will “identify and prioritise elements of international practice that promote public health and patient safety.” So two themes emerge: (1) the role of international standards, and (2) the desire to align with global requirements where possible.
Two changes coming as a result of Brexit are particularly relevant to usability:
New bodies, called Conformity Assessment Bodies (CAB) will perform effectively the same function as Notified Bodies in that they will assess the quality of the technical information supplied by manufacturers, including of course the usability engineering data.
A new mark – the UK Conformity Assessed (UKCA) mark replacing the CE mark – will be available for manufacturers to use from January 1st 2021 onwards. The UKCA mark is mandatory on all devices from July 1st, 2023. So a CAB will need to be satisfied that the quality of usability data is adequate to support this new mark.
In both cases, these changes are significant for usability because they provide the human factors (i.e., usability engineering) process framework by which the quality of data, such as the results of a human factors validation test, will be reviewed as supporting evidence.
What happens for medical device usability requirements?
So, what are the likely implications for medical product developers in terms of usability? Well, to pick up on the points about international standards, and global harmonisation, in some ways the changes are procedural and not particularly substantive and, therefore, the fundamental approaches will not change. Why?
Role of IEC62366-1: MHRA states that international standards will continue to be used. The Usability Engineering standard IEC62366 is recognized by Notified Bodies and is certain to be carried over into the CABs. So this means that manufacturers should continue to use IEC62366-1 as the ”go-to” standard for applying Usability Engineering methods. As we have written previously, there are strong links between the activities recommended in IEC62366-1 and the usability requirements inherent in the European Medical Devices Regulation (MDR).
MHRA Human Factors guidance: MHRA produced their own human factors guidance back in 2017. This guidance recommends an approach to human factors that aligns closely with the US FDA, and also with the requirements in IEC62366-1. We are not expecting MHRA to update this guidance any time soon, so for the foreseeable future they will be the most current guidance from MHRA.
Medical device regulations: The UK Government’s forthcoming regulations on medical device approvals will almost certainly have usability requirements that are identical to those inherent in the EU MDR. This is because the fundamentals of usability engineering (or human factors) do not recognize geography. For example, the need to clearly define intended users and design the medical device in light of users’ capabilities and needs is included in the MDR as well as the US Code of Federal Regulations 820 (Title 21, subpart C, Design controls). It is inconceivable that the UK’s upcoming regulations will differ radically.
Steps manufacturers can take to prepare for MHRA post-Brexit usability requirements
Our advice is to follow the well-established principles and approaches inherent in IEC62366-1. Doing so will provide a robust set of technical usability data that can provide support for review by the upcoming CABs, as well as the EU’s Notified Bodies and indeed US FDA.
Considerations for combination product manufacturers
And what about combination (i.e., drug-device) products such as autoinjectors, inhalers, prefilled syringes, infusion pumps, etc?
Well again, it is highly likely that MHRA will want to see evidence of safe and effective use of the device part of drug-device combination products. Those requirements will be identical to those in the MDR, and also will align with FDA requirements. Therefore, pharmaceutical companies that normally think and plan globally will find it relatively straightforward to adapt to the UK’s requirements.
So, in summary, the advent of Brexit does not appear to change the fundamental requirements of usability engineering.