When does artificial intelligence amount to a medical device and what is changing?


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Artificial intelligence (AI) influences nearly every aspect of modern life. The use of AI is becoming increasingly prominent in health and social care and has the potential both to improve health care for patients and to assist medical professionals to provide treatment faster and more accurately.

Given its usage for diagnostic, monitoring and treatment purposes, many AI programmes in the healthcare sector are regulated as medical devices. However, the existing legislation is not geared towards the regulation of AI and, given its impact upon patients, this is now a key focus for the Medicines and Healthcare products Regulatory Agency (MHRA).

AI is already used successfully in a number of areas such as oncology, and we are now seeing an increased usage of AI across other medical sectors, such as fertility. The law on the usage of AI in Great Britain is already different to that in Europe, and is due to change over the next couple of years with the upcoming future Medical Device Regulations, the implementation of which has very recently been extended to July 2024.

The MHRA announced its 'Software and AI as a Medical Device Change Programme – Roadmap' (Change Programme) in 2021 (last updated in October 2022). The Change Programme includes a number of work packages, with the first tranche intended to be published before the end of 2022. In advance of this upcoming proposed publication date, in this article we review how medical device regulation currently applies to AI, what changes are coming, and what we could expect to see as part of the Change Programme.

How does AI relate to medical devices?

AI is the broad term used to describe the performance of intelligent tasks by machines, especially computer systems. AI based medical devices have the potential to transform healthcare by deriving new insights from current and historical data generated during the delivery of health care services. In recent years, AI has been used to assist healthcare professionals with the detection, diagnosis, and management of diseases and other healthcare issues. AI can also play a role in research, analysing large sets of clinical data to develop applications which generate results much faster than is possible using traditional technologies.

One of the greatest benefits of AI is its ability to learn from real-world use and experience, and its capability to improve its performance based on new data. It is, by its nature, adaptive and self-learning.

Current Medical Device Legislation in Great Britain

The Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), prior to the end of the Brexit transition period, gave effect in UK law to three EU directives, which are the EU AIMDD (Directive 90/385/EEC on active implantable medical devices), the EU MDD (Directive 93/42/EEC on medical devices), and the EU IVDD (Directive 98/79/EC on in vitro diagnostic medical devices).

Different EU regulations apply in EU Member States and Northern Ireland, being the EU MDR (EU Medical Devices Regulation 2017/745, applicable from 26 May 2021) and the EU IVDR (in vitro Diagnostic Medical Devices Regulation 2017/476, applicable from 26 May 2022). These EU regulations did not take effect during the Brexit transition period and therefore do not apply in Great Britain. However, medical devices which conform to the EU MDR or the EU IVDR (and as such are CE marked) can still be registered with the MHRA until 30 June 2024.

The MHRA anticipates that some (but not all) of the changes to be considered in the Change Programme will be in the form of legislation, but many of these changes will be set out in guidance upon legislation, for example by clarifying what medical device requirements mean in the context of software and AI.

Changes to the law

The rapid evolution of AI is a challenging new front in medical device regulation. Huge advances have been made recently in the MedTech, life sciences and diagnostic industries, in particular during the Covid-19 pandemic. The widescale innovative usage of software, and in particular AI, was not envisaged when the existing legislation was adopted. AI-enabled medical devices raise unique regulatory questions due to their iterative and potentially self-updating nature, which is incompatible with current regulation. AI-related risks can also be harder to quantify and mitigate, due to AI's self-improving nature.

The need to change the current law has been recognised by the MHRA, which undertook a consultation on the future regulation of medical devices in 2021-2022 (the MHRA Consultation). One of the areas of focus of the MHRA Consultation was software and AI, with recognition by the then Secretary of State for Health and Social Care Sajid Javid in the government's response to the MHRA Consultation that in the UK "we have a dynamic and pioneering MedTech sector". The NHS is facing ongoing budgetary and staffing challenges, and MedTech is going to be a key part of healthcare, as it can be used by medical professionals to save time and assist with diagnoses. As such, it is becoming increasingly important that medical device regulation is fit for purpose to ensure that healthcare professionals are empowered with the best medical technology available, while also protecting patient safety and taking into regard ethical considerations such as data bias.

The future Medical Device Regulations will represent a substantial reform of the current framework, as detailed in the government's response to the MHRA Consultation. The future Regulations were due to be implemented by July 2023 but this has been extended by 12 months to July 2024 as the government recognises the amount of work to be undertaken to ensure that the future Regulations properly and proportionately regulate AI and software.  The government intends to introduce legislation by Spring 2023 to bring into force transitional arrangements and post-market surveillance requirements.

Software and AI as a Medical Device Change Programme

The MHRA has stated that the aims of the Change Programme are to:

  1. Ensure medical device regulations capture sufficient breadth of software to protect patients and public.
  2. Ensure there is sufficient clarity yet flexibility of qualification to effectively and proportionately regulate software as a medical device or in vitro diagnostic tool.
  3. Improve the wider regulation of digital health, through supporting and working with other regulators and processes where software does not qualify as a medical device.

The first draft elements of the Change Programme intended to be published by the end of 2022 are:

  1. Regulatory guidance upon crafting an intended purpose of a medical device in the context of software.
  2. A review of adverse incident signal detection for software as a medical device.
  3. Good machine learning practice for medical device development mapping.
  4. Best practice guidance on AI as a medical device.
  5. Adaptivity and change management in AI as a medical device.

The MHRA is seeking support and input upon the Change Programme from partner organisations including the Care Quality Commission and NICE as well as the government, the NHS, academia and industry partners. The papers are expected to be published in draft format, and the MHRA will be seeking to engage patients, the public, and the healthcare and industry sectors for wider comment and input before publishing final versions.

What is a medical device?

According to the UK MDR 2002, a medical device is "any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which is intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, or control of conception."

AI and software in general can currently be regulated as components of a physical device, as accessories, or as stand-alone products. 

Deciphering when AI or software amounts to a medical device can be difficult for patients, medical professionals, manufacturers and the MHRA.

There is currently no specific definition of software or AI in the UK MDR 20021. The MHRA Consultation proposed that a new definition be added to the UK MDR 2022 of "software" being "a set of instructions that processes input data and creates output data". No separate definition of AI as part of software was proposed, as the MHRA views AI as a subset of software as a medical device. The outcome of this consultation was that 83% of respondents supported the introduction of this definition of software, and 51% agreed that further definitions were needed.

Our view is that further definitions would also be useful, such as "input data", "output data", "manufacturer", and "AI". The MHRA has stated that it will produce supporting guidance on further definitions. It is worth noting that part of the Change Programme includes bringing clarity over what qualifies as software as a medical device, but this is not included in the first tranche of work.

Registration with the MHRA

All medical devices, including AI which amounts to a medical device, must be registered with the MHRA before being placed on the market in Great Britain (England, Wales and Scotland – different rules apply in Northern Ireland).

A medical device must conform to UK MDR 2002 or, until 30 June 2024, the EU MDR or EU IVDR, in order to be registered with the MHRA. From 1 July 2024, all medical devices used in Great Britain must conform to the UK MDR 2002. It is likely that the new future Regulations will be in force by then, which will doubtless contain further requirements in relation to both medical devices in general and in particular software and AI.

The MHRA will only accept registration of devices from manufacturers where the manufacturer is based in the UK. If a manufacturer of a medical device is based outside the UK, it must appoint a UK Responsible Person. This UK Responsible Person will then assume certain responsibilities on behalf of the manufacturer, including registering the device with the MHRA.

CE marking / UKCA marking

Manufacturers must comply with relevant product marking and conformity assessment requirements for medical devices. This extends to software and apps, although some were given an exception for use in managing the Covid-19 pandemic in the UK.

The UKCA (UK Conformity Assessed) marking is a UK system used in Great Britain only, which is based upon the EU directives which were implemented in the UK by MDR 2002. The UKCA marking is not recognised in the EU, EEA or Northern Ireland.

The European system, CE marking, will continue to be recognised in Great Britain until 30 June 2024 – this was previously 30 June 2023 but a 12 month extension was put in place as part of the transitional arrangements, which will be reflected in legislation in Spring 2023. Certificates issued by EU-recognised Notified Bodies will continue to be valid in Great Britain until that date. Once we reach 1 July 2024 (unless there is another extension), any AI which is a medical device will need to have UKCA marking. This needs to be shown within the software / app, with regulatory information included such as details of the manufacturer.

Trowers & Hamlins' view

The roadmap to effective regulation of AI in healthcare is not a short or simple one, as demonstrated by the staggered release of the Change Programme and the 12 month extension applied in October 2022 to the implementation of the future Medical Device Regulations and ongoing usage of CE markings . It now seems that 1 July 2024 is the date we can expect both the implementation of the future Medical Device Regulations and the change of rules regarding CE marking.

As outlined in the Change Programme there are a large number of areas to be considered in the future Medical Device Regulations and new guidance on medical devices. These are wide ranging and far beyond the issues to consider with medical devices which were initially sought to be regulated, which included items such as treatment chairs, bandages and dental instruments. Our view is that the current legislation is not appropriate for the regulation of AI in healthcare, and that reforms will need to focus upon patient safety, flexibility for innovation and change, quality management, cyber security and compliance with existing data privacy requirements.

The MHRA has recognised the wide range of issues to consider and it is not surprising that it envisages its Change Programme being released in a number of tranches, with input sought from a wide variety of sources. It will take time for the Change Programme to be considered and adopted, which we see as being positive and allowing all interested parties to seek to have input into the final guidance.

Manufacturers of all medical devices need to be aware of the date of 30 June 2024, after which all medical devices used in Great Britain need to be UKCA marked and to conform with the MDR 2002. We also suggest that any interested parties look out for the release of the first tranche of the Change Programme, due to be within the next month, and take part in workshop groups wherever possible.

Questions?

We at Trowers & Hamlins work for a large number of entities within the MedTech Sector, providing expert corporate, commercial and regulatory guidance. Victoria Robertson, one of the authors of this article, has a particular interest in the use of AI in the fertility sector and is the co-chair of the regulatory committee of the international Artificial Intelligence Fertility Society.

If you have any questions or would like further information on the contents of this article please contact us.

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