The New UK Regulatory Framework: We Need Your Help
The MHRA will soon consult on the new UK regulatory framework for medical devices. This is an important and critical opportunity for our industry to input into a key issue that will influence the way we do business for years to come across the whole spectrum of products including devices, diagnostics and digital health.
ABHI will firstly respond to the specifics of the MHRA consultation, but we will also create a separate report that draws contributions from across our membership on what we feel are our industry imperatives. By following this two-pronged approach, our intention will be to support the MHRA in understanding the needs of UK HealthTech businesses.
And so, to deliver these responses, and to seize this opportunity, we need your help. Our initial specific consultation response will help the MHRA to determine the future of patient safety and public health in the UK, by endeavouring to shape the regulatory environment, and to meet the legislative test of ensuring a "favourable place to develop, manufacture and supply medical devices" as found in the Medicines and Medical Devices Act. Importantly, the new UK regulatory framework must reinforce the regulations as being globally aligned, fit for the future and providing patient access to innovative therapies and diagnostics.
Whilst it will be the existing ABHI UK CA Marking member group that will help to coordinate our collective response to the consultation, all ABHI member companies are encouraged to input into the consultation, thereby adding weight to the process and ensuring manufacturer-specific issues are considered.
ABHI encourage all those with an interest in regulation, manufacturing and use of devices in the UK to respond to the MHRA consultation.
The consultation response will be only the first step however. As we have found with submitting earlier reports to the MHRA on innovation and future regulation, our opinions really do matter. So, we will, in addition to working on the consultation, be preparing a wider report on the following deep-dive imperative areas:
1. IVDs
In-line with EU and other global regulatory frameworks, we anticipate the UK regulations will focus on in vitro diagnostic medical devices as a separate type of device. There is much merit in this approach, as not only are the risks and benefits of diagnostics different to therapeutics, the IVD industry in the UK faces some unique challenges from potentially significant changes in the regulation.
2. Digital
From discussions with the MHRA, we can expect a specific focus on digital health. ABHI have already published a white paper on regulatory aspects of digital health which will be a significant contribution to the consultation response.
3. Sustainability
Although we have had little indication from the MHRA on how far the regulations might go to support environmental sustainability, it will be important to reflect on the need for regulatory support to address the potential for inconsistent approaches to sustainability during procurement, including single-use plastics and recycled materials. We may also wish to review regulation and practices around remanufacturing and third-party reprocessing, repair and maintenance.
4. Transition
The success of the regulations will, in the end, be determined by whether industry is able to meet the requirements. Significant changes, a short transition and a hard deadline will lead to many additional challenges for industry looking to meet the new requirements in time.
A phased introduction of the requirements, with straightforward recognition of other regulatory approvals, should be carefully considered.
5 – Research
Patient access to innovative diagnostics and therapeutics requires a new approach to gathering clinical evidence. MHRA regulations should consider streamlined study approvals across the clinical research environment, coupled with a safe environment to introduce new technologies and a recognition of the importance for evidence gathered when devices are used in clinical practice (including registries).
6 - Global Alignment
We will consider the MHRA’s approach to recognising other regulatory approvals, as well as their active participation in the Medical Device Single Audit Program (MDSAP).
To enable input into the above areas, the ABHI UK CA Marking group will seek input from the three existing member groups on IVD regulations, digital health and sustainability. They will also draw on member expertise by forming three new smaller sub-groups specifically for the consultation (transition, research and global alignment).
ABHI will use this unique opportunity to continue our engagement with the MHRA to best represent the HealthTech industry in the UK. We will work closely with our members to collate a comprehensive response to the MHRA that represents the whole industry, to ensure the regulations are globally aligned, fit for the future and give patients access to innovative therapies and diagnostics.
We will alert you when the forthcoming consultation goes live, and will keep you updated throughout the whole process.
Phil Brown, Director, Regulatory & Compliance and Steve Lee, Director, Diagnostics Regulation