The Medicines and Healthcare products Regulatory Agency (MHRA) has the opportunity to create a world-leading environment for medical device use and development that prioritises patient safety while fostering innovation.
Medical devices in the UK are currently regulated under the Medical Devices Regulations 2002 but the landscape of medical devices has changed enormously over the last two decades both in terms of the range of products available and their increasing complexity. The MHRA has noted the “increasingly prominent” role of software and AI within health systems in particular.
Following the July 2020 Independent Medicines and Medical Devices Safety Review Report by Baroness Cumberlege, improving patient and public safety and providing greater transparency of regulatory decision making and medical device information have to be integral features of any changes to the medical device framework.
Against this background, the MHRA’s ‘Consultation on the future regulation of medical devices in the United Kingdom’ - sets out its proposals for changing the current regulatory regime.
In this briefing, we take a closer look at what’s being proposed for medical devices regulation, including how the MHRA plans to meet these dual aims of enhancing patient safety and supporting innovation.
The MHRA’s Consultation, open until 25 November, seeks to gather feedback on proposals which would amend the current Medical Devices Regulations 2002 and update the UK regulatory regime on how medical devices are defined and classified in terms of their risk, in order to keep pace with international best practice and technological developments.
The Consultation puts forward proposals to expand the scope of the definition of ‘medical devices’ to cover a broader range of products than are currently covered by the regulations.
Expanding the definition of ‘medical device’ to include ‘products without an intended medical purpose that have similar functioning and risk profiles to medical devices’.
Broadening the definition of ‘in-vitro diagnostic medical devices’ (IVDs) to include software and other products’.
Are we diverging from the EU regulatory approach?
While the UK can now diverge from EU regulations, much of the content of the Consultation mirrors the changes contained in the new EU regulations relating to IVDs in the EU IVD Medical Devices Regulation (EU) 2017/746 (IVDR). However, the Consultation also aims to fulfil the broader objective of aligning UK regulations with the Global Harmonization Task Force and its successor organisation, the International Medical Device Regulators Forum (IMDRF), with the rationale being that by encompassing internationally recognised definitions, this will improve the status of the UK as an attractive destination for research and development, as well as a hub for the manufacturing and supply of medical devices.
Enhancing patient safety
The consultation is packed with proposals for ensuring that the future regulatory regime for medical devices has patient safety at its heart.
The potential changes cover the entire lifecycle of a medical device and all aspects of medical device regulation, from pre-market approval through to post-market monitoring, with the MHRA treading a difficult line between making sure that its system of regulation is sufficiently robust to ensure medical device safety, without impeding the chances of the UK being seen as a favourable place to develop, manufacture or supply medical devices.
Strengthening manufacturer and supplier accountability by -
Adding to the current list of essential requirements that must be met by manufacturers - e.g. specifying in more detail what information manufacturers must provide with the medical advice, including on labels, as well as plans to specify in more detail what manufacturers should include in their quality management systems to ensure uniformity.
New responsibilities on those supplying medical devices at a distance - e.g. via website or apps, and a range of new requirements around conformity assessments, manufacturers’ pre-market clinical investigations and performance studies.
Improving traceability of medical devices by -
Ensuring all medical devices on the UK market would have to be allocated and labelled with a UDI, enhancing the ability to trace medical devices in the supply chain which would assist health professionals with reporting incidents related to medical devices.
Expanding the MHRA’s current registration database to include more detailed information about medical devices in the UK market, as well as changes to enable the public to search the MHRA’s register for detailed information about a medical device.
Tighter requirements for Approved Bodies -
Proposed changes for Approved Bodies (the organisations designated by the MHRA to assess whether manufacturers and their devices are meeting the regulatory requirements) include setting out more detailed requirements to help drive improvements in how they operate and to harmonise standards across all Approved Bodies, for example in relation to procedures for safeguarding impartiality, plus proposals aimed at increasing visibility around subsidiaries used by Approved Bodies. Approved Bodies will also be subject to a time limit for responding to applications, a welcome requirement after recent pressures but a difficult requirement to meet.
Increased scrutiny for certain types of medical devices -
Under the current regulations, a high proportion of IVDs - e.g. for diagnostic testing of blood or tissue samples - can be placed on the market on the basis of the manufacturer self-declaring compliance with the regulatory requirements. The Consultation includes plans to increase the level of scrutiny for these devices by ‘up-classifying’ them to require Approved Body assessment. Similarly, there are proposals to ‘up-classify’ some implantable medical devices, again aimed at increasing pre-market and post-market scrutiny with a view to greater patient safety. The supply of implantable devices could be limited to specialist centres. Proposals also require the proactive follow-up of patients with such devices.
More stringent post-market requirements -
There are proposals to amend the current regulations to strengthen requirements around post-market surveillance for all medical devices placed on the UK market, including details of what should be included in manufacturers’ post-market surveillance plans. Also being proposed are new criteria and timescales for reporting serious incidents, as well as a requirement on manufacturers to report trends in all types of adverse incidents to the MHRA, whether serious or otherwise. There are also plans for introducing minimum requirements for field safety notices to ensure they are all up to the same high standard and include all the information that MHRA considers important.
Software as a medical device (SaMD) and AI as a medical device (AIaMD) have increased exponentially in terms of the number of settings to which they can be applied in health and social care. Taking this into account, the MHRA is considering changes to the current medical devices regulations to foster further innovation, while balancing the need for patient safety by creating regulations that are clear, effective and proportionate to the risks involved.
Proposals under consideration include:
Software and AI as medical devices - The proposals introduce a number of provisions specifically aimed at regulating SaMD and AIaMD ensuring the regulations are sufficient in scope, including adding a definition of software: “a set of instructions that process input data and creates output data” and following the IMDRF risk categorisation for software as a medical device to more closely align risk classification with international practice.
Early market access - Also being proposed is the introduction of an ‘airlock classification rule’, a provision that would allow some SaMD a temporary high risk classification status where the risk profile is unclear, facilitating earlier access to the market for novel and innovative SaMD whose risk profile needs to be further studied and monitored. It remains to be seen who would be responsible for this monitoring.
Alternative routes to market - The Consultation proposes the introduction of alternative routes to the UK market, such as the MHRA accepting approvals from other international regulators which would then be subject to an abridged domestic assurance process. The MHRA is also considering a pre-market approval route to allow innovative medical devices onto the market for a specified use and time period, subject to certain criteria being met which are likely to include factors such as the size of patient population (rare conditions/small patient groups), the scale of innovation (devices considered as ‘game-changers’ for end users), and the size of manufacturer (targeting small and medium sized enterprises). Manufacturers using this alternative route could be granted approval to make the device available on the market prior to obtaining a UKCA marking, although this would be limited to specific circumstances - e.g. for use on certain groups of patients. As part of this proposal, the MHRA is also considering setting up a hub for innovation which would support manufacturers in research and data-gathering activities, removing the cost and capacity obstacles faced by small and medium sized enterprises in getting innovative products to market.
Enhancing confidence in safety - The dual aims of improving patient safety and driving innovation come together in a number of provisions aimed at tightening existing regulatory requirements around SaMD. It is proposed, for example, to expand the definition of ‘placing on the market’ to include SaMD deployed on websites, app stores and via electronic means. As all devices placed on the market must be registered with the MHRA, this would considerably broaden the reach of the regulations. It is also proposed to strengthen adverse incident reporting mechanisms, by requiring SaMD providers to have a hyperlink to an MHRA-endorsed website where people can report an adverse incident where appropriate, with swift reporting of incidents helping to enhance patient safety and confidence in the use of SaMD.
Separately, the MHRA has published guidance on Software and AI as a Medical Device Change Programme - which contains proposals for reform across the SaMD lifecycle and a number of ‘work packages’ to be delivered over the next two years. The Programme overlaps with and builds on the proposals contained in the Consultation and is intended to provide clarity on standards and processes to meet the MHRA’s objectives, rather than taking the form of secondary legislation. The Programme reiterates the MHRA’s aim of creating a framework that balances the need for responsible innovation with patient safety and contains objectives which specifically relate to AIaMD as a subset of SaMD. These include developing supplementary frameworks that ensure AIaMD placed on the market is safe and effective and is sufficiently transparent to be properly validated. Transparency in the context of the development and use of algorithms will be challenging.
The Consultation will remain open until 25 November 2021. The next step will be to await the Government’s response to the regulatory changes proposed and this is expected in spring 2022, along with the publication of draft regulations. All this is with a view to the new regime coming into effect from 1 July 2023, which is when the MHRA plans to stop accepting CE marked devices in Great Britain and will require the use of UKCA marking.
The medical device landscape has changed rapidly and is set to continue evolving. The Consultation represents a major, comprehensive and much needed opportunity to update the UK’s medical device regulatory framework and future-proof it, taking into account innovation, international best practice and collaboration as well as improved patient safety. The detail of the regulations will be crucial to manufacturers and developers as costs will inevitably be involved in even the smallest of changes. The timeframe for implementation and the transition periods involved will also be critical to ensuring the Consultation’s laudable objectives can be met in practice.