2024 Look Ahead: Spotlight on Regulation
2024 will be another year of hard work for regulatory professionals, whether you are within a Trade Association or a member company. The clarity needed by manufacturers to ensure regulatory compliance over the next few years is still being formulated, even after the recent publication of the MHRA Roadmap. Whilst it has taken a tremendous amount of work to get to this point, and the Roadmap outlines the processes to be followed, certainty as to dates, content, guidance and standards still need to be determined. This matters, because if there is one thing you need as business leaders, it is predictability.
We have raised these concerns with government, and you can expect plenty of communication on this critical agenda throughout the year.
There is, however, no doubt that a new regulatory framework in the UK can potentially revolutionise the market, streamlining innovation pathways as well as maximising the capacity pool and ensuring faster adoption of technologies. ABHI, along with the MHRA and the Department of Health and Social Care, made huge strides last year, but there is still a lot to do. Most importantly, as the expected discussions through 2024 start to become more technically based, the views and input from ABHI members will become critical, ensuring that all of our industry concerns are considered.
Significantly, 2023 saw the UK become increasingly more involved in international affairs, not only in the ongoing discussions around regulatory recognition, but also with the International Medical Device Regulators Forum (IMDRF). As the leading body concerned with global HealthTech regulatory alignment, the IMDRF are largely guided by industry as to topics of concern. Having attended the autumn meetings in Berlin last year, ABHI will be at the next two meetings in the US, supporting the MHRA and other global Trade Associations in these efforts.
The Spring meeting in March will focus on reliance, which is very much a key topic of our UK discussions and will potentially include wider debates on the adoption of Medical Device Single Audit Program (MDSAP) initiatives. It is well known that the FDA is already considering Quality Management Systems as a route to compliance, which lends itself to global recognition through such programmes. With the UK now full and respected members of the IMDRF family, and with ABHI supporting this effort, we, and therefore you, very much have the opportunity of influencing global trends.
But global ambitions will mean very little if we cannot get the UK system right in the first instance. With over 400+ members in the ABHI community now, spanning all product types from medical devices, through diagnostics and digital platforms, there are a lot of diverse opinions to coordinate, all of which are incredibly important. We are lucky as a Trade Association to include both large and small organisations, as well as our professional service providers, such as conformity assessment bodies, consultancies and legal firms. The rounded conversations that we can manage as a result, provide the MHRA, the Department of Health and Social Care, and wider government, with an unprecedented and unrivalled level of input.
In summary, 2024 will not be a year of consolidation, but a year of expansion and refinement. The skeletons of a new regulatory structure are beginning to take shape, but with your help and input, we can add some much needed flesh on these bones.
