The Medicines & Healthcare products Regulatory Agency (“MHRA”) has published a “Consultation on the future regulation of medical devices in the United Kingdom” (the “Consultation”), which will run until 25 November 2021. The consultation sets out proposed changes to the UK medical device regulatory framework with the aim to “develop a world-leading future regime for medical devices that prioritises patient safety while fostering innovation.”
Separately, the MHRA has published a work programme on software and AI as a medical device to deliver a regulatory framework that makes sure that the UK is the home of responsible innovation for medical device software. Any legislative change proposed by the work programme will build upon the wider reforms to medical device regulation being consulted upon as a part of the Consultation.
The MHRA intends that any amendments to the UK medical device framework will come into force in July 2023. This aligns with the date when UKCA marking will become mandatory in the UK and when EU CE marks will no longer be recognized. The MHRA has made clear that it will provide adequate transition periods before adopting any new requirements.
All interested parties are encouraged to contribute to shaping the future regulation of medical devices in the UK by responding to the MHRA’s consultation before the deadline (25 November 2021).
The MHRA’s overarching objectives are to develop a regime for medical devices that enables:
- “Improved patient and public safety;
- Greater transparency of regulatory decision making and medical device information;
- Close alignment with international best practice, and;
- More flexible, responsive and proportionate regulation of medical devices.” (emphasis added)
The Consultation sets out a proposal for a future UK-wide regime to regulate medical devices, which would run in parallel to existing or future EU rules. However, the consultation acknowledges that the MHRA seeks “…greater alignment with … international regimes rather than bringing in higher regulatory burdens.”
The Consultation sets out four “significant areas” that the new regime will focus on, namely:
- “creating new access pathways to support innovations
- a unique, innovative, and ambitious framework for regulating software and artificial intelligence as medical devices
- reforming IVD regulation
- becoming a sustainability pioneer – through safe reuse and remanufacture”
The MHRA has further split these areas into 15 Chapters, which cover: (1) the scope of the regulation; (2) classification; (3) economic operators; (4) registration and UDI; (5) approved bodies; (6) conformity assessments; (7) clinical investigations/performance studies; (8) post-market surveillance, vigilance and market surveillance; (9) in vitro diagnostic medical devices; (10) software medical devices; (11) implantable devices; (12) other product specific changes; (13) environmental sustainability and public health impacts; (14) routes to market; and (15) transitional arrangements.
For each of these chapters, the Consultation indicates how the MHRA proposes to update the UK regulatory framework in line with the overarching objectives detailed above. Many of the principles appear to align with those in the EU Medical Devices Regulation 2017/745 (“MDR”) and EU IVD Medical Devices Regulation (EU) 2017/746 (“IVDR”), which is not surprising given the UK was a key player in the development of the MDR and IVDR. It is clear, however, that the UK intends for broader alignment with international standards (e.g. the IMDRF) rather than simply aligning with the EU regulatory framework.
Impact on Software and AI
The MHRA acknowledges that software and AI are developing fast and play an “increasingly prominent role within health systems” and that UK device regulation needs to be updated to both protect patient safety and also keep up with technological advances.
Chapter 10 of the Consultation sets out proposed changes for “Software as a Medical Device (SaMD), including AI as a medical device (AIaMD).” The Consultation provides a detailed overview of changes, including defining software, introducing requirements for persons selling SaMD via electronic means, adopting the IMDRF Risk Categorization for SaMD and defining specific requirements for AIaMD (amongst others).
Separately, the MHRA published details of an extensive work programme to inform regulatory changes for software and AI devices. These aim to ensure that:
1. “The requirements for software and AI as a medical device provide a high degree of assurance that these devices are acceptably safe and function as intended, thereby protecting patients and public
2. That the requirements are clear, supported by both clarificatory guidance and streamlined processes that work for software, as well as bolstered with the tools to demonstrate compliance, for instance, via the designation of standards
3. That friction is taken out of the market by working with key partners such as the National Institute for Health and Care Excellence and NHSX to align, de-duplicate, and combine requirements, ultimately providing a joined-up offer for digital health within the UK.” (emphasis added)
The programme includes 11 work packages over two workstreams. The work packages relate to: (1) qualification; (2) classification; (3) pre-market; (4) post-market; (5) cyber secure medical devices; (6) innovative access; (7) SaMD airlock; (8) mobile health and apps; (9) AI rigour; (10) AI interpretability; and (11) AI adaptivity.
The MHRA plans to deliver these work packages between autumn 2021 and summer 2023. It is anticipated that much of the reform from the work packages will be in the form of clarificatory guidance, standards, or processes rather than secondary legislation. Any legislative change proposed by any work package for software/AI will build upon wider reforms to medical device regulation being consulted upon as a part of the Consultation.