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UK to update regulations on Software and AI

Published by Alec Denniff, Medical Device Paralegal on

Last September, the Medicines & Healthcare products Regulatory Agency (MHRA) launched a change programme on ‘Software and AI as a Medical Device’. This was intended to ensure that the regulatory requirements for software and AI are clear for manufacturers. The programme compliments wider reforms on medical devices as a whole, forming the basis for the software and AI proposals in the MHRA’s Consultation on the Future Regulation of Medical Devices in the UK. Much of the change programme was included in the government’s response to the consultation. 

Two of the most important topics from the change programme concern the qualification of software and AI as medical devices, and the classification of these products.

Qualification

Recognising a lack of clarity regarding what software qualifies as software as a medical device (SaMD) and software in a medical device (SiMD), the MHRA noted its intention to:

  1. Ensure that the medical devices regulations capture sufficient breadth of software to protect patients and the public
  2. Ensure that there is sufficient clarity, and flexibility, for when software qualifies as SaMD
  3. Improve the wider regulation of digital health, by supporting and working with other regulators and processes, where software does not qualify as SaMD

The government’s response to the consultation outlines changes to implement these intentions in the new Medical Devices Regulations. This includes the introduction of a definition of ‘software’ into the Regulations, as “a set of instructions that processes input data and creates output data.” This definition is identical to the definition of software used in the EU, set out in MDCG Guidance 2019-11.

However, this is the only definition relating to software due to be added to the actual regulations. Noting interest in defining other terms related to software (e.g. input data, output data, AI, software accessory), the response states that clarity on these terms will come from supporting guidance. Guidance from the MHRA is also expected on other topics relating to software, including:

  • SaMD compared to wellbeing and lifestyle products
  • Medical device software and IVD software
  • Requirements that might apply to ‘in house’ SaMD’.

It is also expected that additional guidance will be forthcoming in the UK Borderlines Manual, including examples to illustrate boundaries or borderline products.

Classification

The UK Medical Devices Regulations do not currently classify software proportionate to the risk it might pose to patient and public safety. This is unlike other classification systems used for medical devices (e.g. EU, AU), and puts the UK Medical Devices Regulations out of alignment with the international approach.

The MHRA recognised the risks posed by the current approach in the change programme, and set out to:

  1. Ensure classification rules closely follow the risk that SaMD poses to patient and public safety
  2. Ensure classification rules impose safety and performance requirements proportionate to the risk that SaMD applications pose
  3. Ensure that classification rules do not unnecessarily restrict innovation, but provide enough flexibility so that novel devices can be addressed

The change programme proposed a classification framework for SaMD similar to the rules used by the International Medical Device Regulators Forum (IMDRF). This is now confirmed by the government’s response. However, this will not apply to IVDs, as the IMDRF categorisation framework “significantly diverges from the EU IVDR classification system” and would put the UK out of alignment with the EU in respect of classifying IVD software. 

On the topic of novel devices and restricting innovation, the MHRA’s change programme had discussed the possibility of introducing an ‘airlock process’ for innovative SaMD products meeting a critical unmet clinical need. This process would allow for an ‘airlock classification rule’ - a provision providing a temporary classification for the SaMD products. Whilst the product would likely be subject to monitoring and restrictions as if it were a high-risk device, it would be allowed on the market until the risks of the product are properly understood. This proposal received support in the MHRA consultation, but the government does not intend at this stage to proceed with the airlock process. Instead, the government plans to consider this further in a future public consultation. 

The MedTech industry is awaiting the publication of the updated Medical Devices Regulations, which are scheduled to come into effect mid-2023. If you are interested in finding out how the IMDRF SaMD categorisation framework would apply to your product, please register your interest in our AI-powered guide to the medical device regulations (below). Our guided assessment incorporates all official updates to the regulations and can help you navigate the complicated regulatory maze.