22 September 2021

Digital Health in the UK: MHRA Bold New (Regulatory) World?

In his statement to the House of Lords on September 16, Lord Frost announced that “we will use the provisions of the Medicines and Medical Devices Act 2021 to overhaul our clinical trial frameworks, based on outdated EU legislation, giving a major boost to the UK’s world-class R&D sector and getting patients access to new lifesaving medicines more quickly. The MHRA which is a world class regulator as we know, is already reforming the medical devices regulations to create a world-leading regime in this area.” This provided a timely back-drop to the MHRA’s new publications on medical device software, and part of a broader agenda for regulatory change in the UK.

Accordingly, the MHRA has opened its anticipated Consultation on the future regulation of medical and in vitro diagnostic (IVD) devices in the United Kingdom, setting out the upcoming legislative changes, which runs until November 25, 2021. The heart of this proposal is to create a flexible and “fluid” framework, dynamic to adapt to, and embrace, emerging innovation while maintaining patient confidence. Covering fifteen key areas of regulation, the proposal addresses classification, economic operators, clinical investigations/performance studies, software as a medical device (including artificial intelligence (“AI”)) and, even more interestingly perhaps, there is a chapter titled “Routes to Market.” This new chapter explores the creation of an alternative pathway to market devices that address small patient groups, are innovative, and/or are manufactured by SMEs, thus signalling the UK regulator’s flexibility, innovativeness and commitment to prioritising patients.

To clarify the future policy position on software as a medical device (“SaMD”) and AI in the UK, the MHRA has published a new set of “work packages,” the key elements of which are to be delivered from autumn 2021 until summer 2023, with the aim of the UK becoming the “home of responsible innovation for medical device software.”

The publication provides a set of guiding principles for the development of regulation for medical device software in the UK, addressing each stage in the lifecycle of products, from classification through to post-market surveillance. Of particular note are: (a) the proposal in work package 6 for a novel expedited market route for SaMD akin to the Innovative Licensing and Access Pathway (ILAP) which already exists for medicines, and (b) work packages 9-11, which propose broad suggestions for the use of AI in medical devices. It is not yet clear how these AI proposals will align with the National AI Strategy set to be published later this year. [A summary table of the work packages is below/ at the end of the article.]

Alongside these changes, the UK legislators are exploring a new data rights regime, which they characterize as “more proportionate and less burdensome than the EU’s GDPR.”

The UK has certainly set itself an ambitious target for the new medtech regulation, with a focus on increased flexibility and reduced regulatory burden to accommodate safe and effective innovation of high quality. Inevitable concerns around regulatory divergence with the EU post-Brexit, and the implications of parallel regimes can be addressed by the MHRA’s emphasis on international alignment and coordination, as has been the case in the medicinal products space (e.g., the MHRA joined international access consortia such as Project Orbis and the Access Consortium, resulting in collaboration with ex-EU regulatory agencies).

Indeed, the proposals embrace many of the principles set out in the EU Medical Device Regulation but also look to reflect principles and standards set by the International Council for Harmonisation of Technical Requirements Human Use (ICH), the International Coalition of Medicines Regulatory Authorities (ICMRA), and the International Medical Device Regulators Forum (IMDRF). The MHRA, an established and influential regulator, is taking steps to deliver on its promise to make the UK a friendly and helpful home for medical device and digital health innovation. With the right involvement from industry and the public, and owing to mutual recognition and reliance procedures within this environment of international coordination, the new UK regulatory system can set the tone of digital health regulation in other jurisdictions.

The work packages relating to Software and AI are summarized below:

1. Qualification

Ensure medical device regulations capture sufficient breadth of software; in a clear, flexible, yet proportionate way; and result in a uniform approach to regulating digital health even outside the medical device framework.

2. Classification

Ensure classification rules reflect risk, imposing proportionate safety and performance requirements and offering flexibility to accommodate the risk profile of novel devices.

3. Pre-market

Ensure safety, efficacy and quality of SaMD through clear premarket requirements particularly on clinical evidence and clinical investigations; and through appropriate registration requirements to support a robust post market surveillance system for SaMD.

4. Post-market

Implement a robust post market surveillance system, providing clear change management requirements and processes and allowing for quicker and thorough capture of adverse incidents for SaMD, for instance through use of real world evidence (“RWE”) to monitor and ascertain performance of SaMD.

5. Cyber Secure Medical Devices

Articulate how cybersecurity issues can translate to SaMD safety issues and address it in premarket and in post market surveillance requirements and also work closely with other relevant bodies to ensure consistency of SaMD cybersecurity requirements.

6. Innovative Access

Explore the need for and likely construction of a novel pathway to market for medical devices and digital health technologies akin to the Innovative Licensing and Access Pathway (ILAP) based on critical need, innovation, and compelling benefit.

7. SaMD Airlock

Explore the need for and an appropriate mechanism for an “airlock classification rule” to enable interim market access for novel and innovative SaMD whose risk profile needs to be further studied and monitored.

8. Mobile Health, and Apps

Ensure a safe, effective and quality mHealth SaMD market that can address and minimize any safety concerns and risk to the public.

9. AI: Project AI RIG (AI Rigour); Project Glass Box (AI Interpretability); Project Ship of Theseus (AI Adaptivity)

The aims for AI are threefold:

  1. Develop frameworks and technical methods to ensure AI as a medical device (AIaMD) is safe and effective and fit for purpose for all (AI Rigour)
  2. Ensure transparency in AIaMD so that AI models can be testable, validated and robust and usable, safe and effective for all users (AI Interpretability)
  3. Address and distinguish adaptive AIaMD, clarifying how it fits within medical device regulations and ensure that new guidance addresses change management processes.
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