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MHRA Announce Work Programme on Software and AI as a Medical Device

on Wednesday, 13 October 2021.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new work programme to provide a regulatory framework for software and AI medical devices.

The work programme will contribute to a regulatory framework which protects individuals whilst also fostering innovation, a key part of the Government's strategy for the UK to cement its position as world-leader for innovation in life sciences.

The work programme relates to software as a medical device (SaMD), which will include consideration of pure software medical device solutions, and also software that is incorporated into hardware medical devices. The goal is to produce clear, user-friendly and enforceable requirements that ensure SaMD is safe and functions as intended. The MHRA will work with other organisations such as NHSX (the joint government, NHS and industry unit focused on creating a technologically advanced health and care service) and NICE (the National Institute for Health and Care Excellence) to provide a joined up approach.

It is envisaged that the work programme will primarily produce guidance, standards and/or processes rather than legislation. Any legislation proposed by the work programme will be part of wider reforms to medical device regulation that the MHRA is already working on. The work programme is aligned with the MHRA's open consultation on the future regulation of medical devices in the UK, which is focusing on changes to the regulation of medical devices in the UK more generally, including policy and legislative changes.

Coronavirus guidance employers

The work programme is divided into several different work packages with different objectives, including work packages relating to:

  • Qualification - what will qualify as a medical device?
  • Pre-market - how can we ensure SaMD is safe and effective before going to market?
  • Post-market - how can we monitor SaMD on the market to provide further assurance of safety and efficacy?
  • Cybersecurity - how can we incorporate cybersecurity issues into SaMD safety requirements?
  • Innovative access - will there be special rules for SaMD's pathway to market?

For more information, see the guidance. The MHRA intends to release roadmaps for work packages detailing wider reforms before the end of 2021, so watch this space.

PING Conference 2021

The 2021 PING Conference, which VWV will be holding in collaboration with IQVIA, is entitled 'UK Life Sciences Opportunities in a Changed World'. The Conference will look at many ways in which the UK is now innovating and bringing new treatments to patients. This will include hearing from Dr Kirsty Wydenbach, Expert Medical Assessor and the Deputy Unit Manager in the Clinical Trials Unit at MHRA, who will be speaking about 'MHRA innovation supporting the UK to be a global life sciences super-power'. Find out more about the PING Conference 2021.


For more information on software and AI as medical devices, please contact Penelope Jones, in our Technology and Pharmaceuticals and Life Sciences teams on 07384 813071, or please complete the form below.

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