On 16 September 2021, the UK MHRA launched its awaited “Consultation on the future of medical devices regulation in the United Kingdom” (available here). At the same time, it announced a separate (but related) work program for the regulation of software and artificial intelligence (AI) as a medical device, see press release here.
Reform of the UK’s regulation of medical devices has been much anticipated since Brexit and the consequent divergence from the EU system, and the MHRA has recognised that the current situation post-Brexit has left the UK out of step with international best practice and technological developments. At the same time, the rhetoric is positive about the MHRA’s new-found regulatory freedom and the opportunities this presents. Introducing the proposals, Secretary of State for Health and Social Care, Sajid Javid, hailed the “newfound regulatory freedom and a unique chance to reshape our rules” following departure from the EU.
The overhaul contemplated by the MHRA is wide ranging and shows that the MHRA is unafraid to flex its muscles. The proposals cover the full medical device life cycle from pre-market approval, through to supply and post-market monitoring, and include significant changes in scope and classification (e.g. regulation of software and AI as a medical device), placing more stringent requirements on manufacturers (e.g. increased information requirements) and tightening of vigilance measures.
The Consultation was prefaced by the MHRA in its Delivery Plan 2021-2023 and echoes some of the recommendations set out in the Regulatory Horizons Council Report on Medical Devices of August 2021. Twin policy aims of increasing safety while fostering innovation are emphasised throughout and respondents are asked, in particular, to assess proposals against three criteria: safety of medical devices; availability of medical devices; and the likelihood of the UK being seen as a favourable place in which to research, develop, manufacture or supply medical devices. In keeping with the innovation objective, the MHRA also hints there will be increased emphasis on guidance than there is currently, to ensure the ability to “keep pace with dynamic innovation in medical technologies”.
The proposals range from those which are quite technical and detailed to others which are pitched at the policy level. Some of the key proposals for consultation include:
- Substantial changes to the scope and classification of medical devices, including increasing the scope of regulated devices (e.g. dermal fillers), and increasing the classification of certain devices (e.g. surgical mesh);
- Wide-ranging changes to requirements for economic operators (such as manufacturers) including:
- Introducing UDIs (Unique Device Identifiers),
- More stringent information requirements upon registration,
- Requiring manufacturers to have “measures” in place in respect of adverse incidents, such as legal liability insurance,
- Regulating marketing claims made about medical devices (including prohibiting misleading claims);
- More stringent Approved Body and conformity assessment requirements;
- New rules for clinical evaluations and performance studies, including tightening requirements for claiming equivalence to another device;
- Transformation of the regulation of software and AI as a medical device (see further below);
- Tightened post market surveillance and vigilance, including incident and trend reporting; and
- Consideration of possible new routes to market, including consideration of equivalence with international routes.
The Consultation closes on 25 November 2021, and the plan is for the amendments to come into force from July 2023 to align with the date from which the UK will stop accepting CE marked medical devices and will begin requiring UKCA marking. The MHRA is also consulting on potentially broad transitional arrangements.
In respect of software and AI, the MHRA proposes transforming the regulation of software as a medical device (SaMD) and including AI as a medical device (AIaMD). This is covered in the Consultation (Chapter 10) where the MHRA consults on a range of proposed changes (e.g. definition and regulation of sale via electronic means), and is also the subject of a separate extensive (albeit high level) Work Programme published in parallel. The MHRA recognises the “increasingly prominent” role of software and AI within health systems, ranging from screening to diagnosis to treatment, and announces the intention to update regulatory measures to “further protect patient safety and take account of these technological advances” and to capture these applications of software and AI throughout the device lifecycle.
Eleven work packages are detailed across two workstreams, including: appropriate qualification and classification of the software that will fall in scope; developing appropriate pre- and post-market requirements; and a specific work programme targeted at Mobile Health and Apps to triage and address “safety or effectiveness concerns”. The MHRA anticipates that it will meet its objectives in the software sphere via clarificatory guidance, standards or processes rather than secondary legislation, and regulation here will build upon the wider reforms detailed in the Consultation. The MHRA reports that it has been working with opposite numbers in “key jurisdictions” and international bodies on many of the work packages and trails that the “fruits of some of this work will be revealed soon”.