Posted: 16/01/2025
With the emergence of artificial intelligence (AI) and other machine learning methods, software-based medical devices are a substantial growth area in the medical devices sector and an increasingly common feature in everyday life.
With this in mind, the Medicines & Healthcare Regulatory Agency (MHRA) recently published a consultation entitled ‘Medical Devices Regulations: Routes to market and in vitro diagnostic devices’. Launched on 14 November 2024, this consultation is the latest phase in a process of regulatory change which will have important implications for businesses seeking to put software-based medical devices on the UK market.
This article highlights the key changes that have happened in the regulatory arena in recent months and considers what further changes might be coming down the pipeline.
The MHRA’s latest consultation on medical devices regulations sprang from its roadmap towards a future regulatory framework for medical devices, which was first announced in January 2024. Prior to the MHRA launching its initial roadmap, the prospect of change for the regulation of software as a medical device (SaMD) was already firmly on the agenda.
The Medicines and Medical Devices Act 2021 signalled the beginning of the UK’s divergence from the EU’s regulatory framework after Brexit. As described in a previous article, this act paved the way for the UK to make its own regulations in relation to medical devices, including SaMD. Developments in recent months have shown that the MHRA and the government are now taking steps to shape this regulatory landscape.
Prior to the MHRA launching its roadmap, the regulator had already made a number of significant moves in relation to the regulation of medical devices. Most importantly, it recognised that manufacturers of medical devices need certainty about which regulatory regimes to follow when bringing products to market whilst further reforms are contemplated. In this vein, the MHRA announced an extension for the recognition of some CE marked medical devices, including some SaMDs in the UK market, until 30 June 2030, as set out in detail on the gov.uk website here. This extension of the transition period allows manufacturers of these devices to continue selling CE marked medical devices in the UK until the new deadline.
As it stands, after 30 June 2030, a UKCA mark will be required for all medical devices to have continued market access in the UK. This extension provides a significant buffer period for manufacturers to transition to the new UKCA marking requirements. Interestingly, in a consultation launched in November 2024, the MHRA asked for views on the possible introduction of a unique device identifier, which would remove the need for a UKCA mark entirely. Whether this occurs will depend on the consultation’s outcome.
After the MHRA announced its initial roadmap, a number of other important developments have taken place, which may impact businesses looking to put software-based medical devices on the UK market.
The MHRA released new guidance on software and artificial intelligence as medical devices which was updated in June 2024. The update offers a high-level overview of the current guidance and the ongoing change programme in this area, including in relation to the classification of software-based medical devices. Changes made to regulations since December 2023 are highlighted, reflecting the evolving landscape of medical device regulation and the increasing integration of AI technologies in healthcare.
In addition, on 13 June 2024, the MHRA (in collaboration with Health Canada and the FDA) published guiding principles for transparency for machine learning-enabled medical devices (MLMDs). The update emphasised the importance of effective transparency, which involves timely communication of information on risks and patient outcomes, considering the intended user, context, and environment. The guiding principles in the publication reiterate common sense guidance and it serves as a crucial resource for ensuring transparency in the development and deployment of MLMDs.
The MHRA published an updated road map in December 2024 which sets out timelines for additional consultations, legislation delivery, and the implementation of regulatory changes. Key dates include the introduction of post-market surveillance regulations in summer 2025 (see details below), ongoing consultations on pre-market requirements until mid-2025, and the planned implementation of new legislation by early 2026. This update provides a welcome indication of timings to industry stakeholders wanting to ensure they are well-prepared for upcoming obligations. However, what remains unclear is the duration of any implementation period once updated UK regulations are in force, and how that will impact medical devices companies.
Recent months have also seen changes to the law in the form of the draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. Through these regulations, the government will introduce significant updates to its framework for medical device regulation and the requirements for post-market surveillance (PMS) of medical devices. These new regulations mandate that manufacturers implement a robust PMS system, including the creation of a periodic safety update report for medium or high-risk devices. Additionally, manufacturers are now required to conduct periodic reviews of PMS data to identify safety trends, ensuring continuous monitoring and improvement of device safety.
The draft regulations also enhance reporting obligations for serious safety incidents and introduce stricter requirements for issuing field safety notices when a serious issue is detected. Manufacturers must implement field safety corrective actions to mitigate risks and prevent further incidents. These changes aim to bolster the safety and effectiveness of medical devices, particularly those that are software-based, by ensuring rigorous post-market oversight and prompt action when safety concerns arise.
While guidance and new regulations were already forthcoming in 2024, the MHRA’s December 2024 consultation is a further sign that the regulator is intent on continuing to grapple with difficult questions in relation to the regulation of an evolving industry.
This consultation includes details of a proposed international reliance scheme for countries with comparable regulatory systems. If brought in, this would allow companies manufacturing medical devices to rely on regulatory approval they have received in territories such as Australia, Canada, the USA and EU (referred to as ‘comparable regulator countries’ or ‘CRCs’) in order to bring their devices to market in the UK under a more streamlined regime. This would be an incredibly beneficial step to promote the deployment of novel medical devices in the UK market.
To address safety concerns, initially, all software as a medical device will only be eligible for ‘Route 4’ approval. The requirements for SaMDs under Route 4 include confirmation of a CRC’s marketing authorisation, the device’s GB classification, GB requirements, a review of the PMS plan, and a review of PMS data from the last five years where available.
In the UK, in contrast to the other CRCs, manufacturers of the majority of software-based medical devices can currently self-certify and launch their products as Class I medical devices based on the current UK regulations for classification. The classification of SaMD once new rules are in place in the UK will mean that most SaMDs will be classified as Class IIa, with the increased regulatory requirements that entails. This will bring the UK into line with the classification rules for the other CRCs and underlines the MHRAs approach to implementing an internationally consistent standard for medical devices.
In the midst of these shifting sands, some useful resources to support developers and adopters have come online. The AI and Digital Regulations Service (AIDRS) is a collaborative initiative by the National Institute for Health and Care Excellence (NICE), the MHRA, the Health Research Authority and the Care Quality Commission. Launched in April 2024, the AIDRS website serves as a comprehensive guide for developers and adopters navigating the complex regulatory pathways for software as a medical device, including AI.
The AIDRS is a valuable resource, covering requirements from all the involved organisations. Additionally, the AIDRS consolidates guidance on NICE requirements, highlighting differences between MHRA approval and NICE's Evidence Standards Framework. It also addresses other regulatory aspects, such as compliance with UK data protection laws during the development and deployment of software as a medical device.
The above summary demonstrates that producers of software-based medical devices are navigating an ever-evolving regulatory landscape with unclear implementation timeframes, making it crucial for businesses in the sector to stay informed about the latest developments.
Keeping up to date with these changes has never been more important to ensure compliance and market access. This is where we can assist, providing the expertise and support needed to stay ahead in this dynamic environment.
This article was co-written by Jake Watts, trainee solicitor in the commercial, IP, IT team.