Executive summary
The Regulatory Horizons Council (RHC) report on medical devices comes at an opportune time. Following the UK’s withdrawal from the EU and the Medicines and Healthcare products Regulatory Authority’s (MHRA) consultation on the future regulation of medical devices, the government is well placed to take forward the report’s recommendations and deliver a world-leading regulatory framework.
This response addresses the report’s recommendations in 4 key areas:
1. Patient outcomes and safety
By building greater patient engagement into the regulatory framework and enhancing the reporting of safety risks, we will ensure a system that is centred on the needs and safety of patients.
2. International leadership and engagement
Positioning the MHRA as a world-leading regulator, the new framework will expand international engagement and establish the UK as a pioneer in the regulation of emerging technology, including software as a medical device and in-vitro diagnostics (IVD).
3. Investment in regulatory capacity
We will maximise the opportunities offered by the transition to UK Conformity Assessed (UKCA) marking – not only increasing the number of UK approved bodies to meet capacity, but also exploring opportunities to increase UK-based regulatory expertise.
4. Unlocking innovation and emerging technology
The MHRA is committed to supporting responsible innovation while minimising risk to patients and the public. Across government, we will continue to explore pathways to bring the most transformative emerging technologies to market and to the NHS, and attract investment in innovative devices.
Introduction
The RHC is an independent expert committee that identifies the implications of technological innovation, and provides government with impartial, expert advice on the regulatory reform required to support its rapid and safe introduction. The RHC is supported by civil servants from the Better Regulation Executive (BRE) in the Department for Business, Energy and Industrial Strategy (BEIS)
The RHC published its report on medical devices on 19 August 2021, in response to rising complexity of medical technology and the opportunities for global leadership that EU exit has enabled. It sought to answer the following question: ‘How can the UK encourage international investment and innovation and improve safety in the medical devices area through regulatory and non-regulatory changes?’. The RHC engaged with industry experts and across government, and commissioned evidence.
The government has considered each of the report’s 11 recommendations and this response focusses on the actions being taken in response.
This response builds on the government’s response to the MHRA’s consultation on the future regulation of medical devices, published on 26 June 2022, which confirms the direction of travel for medical devices regulation in the UK. Having left the EU, we have been given a substantive opportunity to update and improve the UK’s medical devices regulatory landscape, supporting the growth of the UK life sciences sector. Full details of the future regulatory framework for medical devices can be found in the government’s response and appropriate references are included in this document.
Summary of the government response to each of the report’s recommendations
Building a regulatory system for medical devices that works for patients
Recommendation 1
The regulation of medical devices should be centred on the needs of patients, informed by patients, record outcomes that matter to patients, and provide evaluations that are understandable to patients.
Government response – accept
The government recognises and supports the MHRA’s delivery plan 2021 to 2023 Putting patients first: a new era for our agency, which sets out the MHRA’s roadmap for the future, centred on better public and patient involvement throughout their work.
This delivery plan has initiated a substantial programme of work to:
- improve how it listens and responds to patients and the public
- develop a more responsive system for reporting adverse incidents
- strengthen the evidence to support timely and robust decisions that protect patient safety
This emphasis has already had an impact on how the MHRA works with patients in tangible ways. For example, the MHRA actively engaged with patient representatives in the development of the policies for the future regulatory framework for medical devices, during the public consultation that ran in autumn 2021, with over 300 attendees joining a public engagement session in October 2021.
The MHRA will continue to actively engage stakeholders, including patient representatives, in a series of planned focus groups. The focus groups will commence in January 2023 and will meet regularly to provide guidance around the chapters of the government response. A series of one-to-one meetings with patient representatives is also planned and will feed into all focus groups to gather patient input across a total of 20 topics for the guidance and other support materials necessary to aid transition to the amended regulatory system.
The government will continue to monitor the impact of the MHRA’s delivery plan and ensure that patient-centred regulation becomes embedded in the MHRA’s ways of working.
Increasing capacity to address present needs and emerging opportunities
Recommendation 2
Strengthen and increase funding to the MHRA to significantly expand their capacity in medical devices, including in emerging technologies.
Government response – accept in principle
The government continues to support the appropriate funding required for the operation of the MHRA, taking into account all of its functions. The MHRA’s regulatory functions for medical devices are primarily funded by the Department of Health and Social Care (DHSC), with the remaining revenue from fees charged for services.
In August 2022, the MHRA launched a consultation on proposals for changes to their statutory fees. The proposals are intended to ensure the MHRA is adequately resourced, including in areas of technological progress in medical devices where increased resource is required.
Recommendation 3
Address bottlenecks in the approval of medical devices, notably the shortage of UK approved bodies for conformity assessment.
Government response – accept
The MHRA focuses on ensuring conformity assessments are carried out consistently and robustly by UK approved bodies (ABs), which must effectively assess medical devices to assure their safety, quality and performance. View a list of UK approved bodies for medical devices.
The MHRA is currently reviewing several applications from organisations that have applied for designation as a UK approved body (AB). The MHRA is also actively working with organisations that are preparing to apply for UK AB designation either through new applications or extending their existing scope for conformity assessment.
Further information on mitigations for bottlenecks in the approval of medical devices is detailed in the response to recommendation 4 below.
Recommendation 4
Prepare mitigations that supplement AB capacity to ensure supply of devices after transition to UKCA.
Government response – accept
The MHRA has been exploring options to mitigate AB capacity issues, and will continue to communicate with industry for views to ensure there is a smooth transition to any regulatory changes, recognising that the medical devices sector requires time to make changes.
To address anticipated challenges relating to AB capacity, the future regulatory framework for medical devices will set out the government’s plans for a phased introduction of the proposed requirements to ensure there is a considered approach to implementation. This will allow manufacturers to leverage certification under the existing UKCA and CE marking processes.
Devices that are UKCA marked under the existing UK regulations prior to the new regime taking effect will be permitted to continue to be placed onto the GB market for 3 years for general medical devices and 5 years for in-vitro diagnostic (IVD) medical devices or until their current certifications expire, whichever is sooner. This will allow for the upscaling of the approved body capacity.
Devices that are CE marked under EU legislation will be permitted similar transition timescales and these will run from 1 July 2024, when the new regime is planned to come into effect. For devices CE marked under the EU directives (former EU legislation), these timescales will be 5 years for IVD medical devices and 3 years for other medical devices, or until their certifications have expired, whichever is sooner. For devices CE marked under the new EU regulations (EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)), it will be permitted to place these devices onto the GB market for up to 5 years from 1 July 2024.
It is not anticipated that an extension of this provision will be required, as the intervening period will be used to support an increase in AB capacity to ensure the UK has sufficient capacity to transition all medical devices to the UKCA marking system. The MHRA will also be working to build the UKCA marking for medical devices on a global standing.
These approaches have been designed specifically to alleviate pressure on ABs, given current capacity restraints. The phased implementation of the new regime has also been developed to prioritise patient safety and minimise the risk of critical supply issues, ensuring the continued safe supply of medical devices to the UK market.
International leadership and partnership in medical devices
Recommendation 5
Support the MHRA to increase UK visibility, international engagement and leadership.
Government response – accept
The government’s response to the MHRA’s consultation outlines the future regulatory framework for medical devices, which includes proposed changes that will position the MHRA as a world-leading regulator.
The future regulatory framework will be unique, innovative and ambitious in areas such as software as a medical device, artificial intelligence as a medical device, and IVDs, while maintaining a focus on patient safety. This leading regulatory model will put the MHRA in a leadership position among international peers in addressing challenges such as proportionate regulation of software as a medical device, ensuring that the UK attracts a world-class life sciences industry. Through the coronavirus (COVID-19) pandemic, the MHRA has shown itself to be one of the world’s foremost regulators – and true innovators.
The MHRA has recently gained full membership of the International Medical Devices Regulators Forum (IMDRF), a group of 10 regulatory authorities focussing on accelerating international medical device regulatory convergence. As a full IMDRF member, the MHRA will be able to take a greater international role in promoting an efficient and effective regulatory model for medical devices, responding to emerging challenges while protecting and maximising public health and patient safety.
The MHRA is also an official observer of the Medical Device Single Audit Programme (MDSAP). MDSAP is a way in which manufacturers can seek a single assessment of conformity of their quality management systems against the regulatory requirements for any of the 5 full member states: Australia, Brazil, Canada, Japan and the US.
More specifically, the MHRA has worked with the US Food and Drug Administration (FDA) and Health Canada to publish an agreed list of 10 Good Machine Learning Practice Principles (October 2021). This document is intended to ensure aligned thinking between the regulators and is the first step of collaborative work in this area between regulators. Building on this collaboration, the MHRA continues to strengthen their relations and are working together to deliver further documents to ensure internationally aligned thinking on artificial intelligence (AI) and machine learning-enabled medical devices. In addition, through participation of the IMDRF, the MHRA is developing AI-specific guidance that will set the global standards for regulatory compliance.
More widely, the MHRA has collaborated with the NHS Transformation Directorate on the G7 health track digital health proposal on AI governance as part of the UK delegation (paragraphs 40 and 41, G7 Health Ministers Declaration). Through this work we are contributing to the international dialogue on digital health and providing recommendations on how countries can work together to ensure their citizens can benefit from digital health technologies.
The MHRA is working closely with the British Standards Institute (BSI) in its roles as the UK national standards body and a global standards promoter in partnership with their US counterpart, the Association for the Advancement of Medical Instrumentation (AAMI). The MHRA contributes to several standards committees in this space, namely: BS30440 Validation Framework for the use of AI in Health and Care, and Committees: CH/62/2 Diagnostic Imaging Equipment, CH/62/3 Equipment for Radiotherapy, Nuclear Medicine and Radiation Dosimetry, and IST/35 Health Informatics. Additionally, the MHRA also provides input on many of the major reporting guideline variants for AI, such as CONSORT-AI, SPIRIT-AI, and DECIDE-AI, increasing the MHRA’s international engagement and leadership in developing regulatory guidelines.
This international work is a key component in ensuring alignment and the long-term success of MHRA’s domestic legislative and regulatory guidance plans for the future regulation of software as a medical device (SaMD) and artificial intelligence as a medical device (AIaMD).
Recommendation 6
Invest in the UK as a global centre for regulatory science and the training of regulatory professionals with expertise in medical devices, including in emerging technologies.
Government response – accept in principle
The government’s current focus for medical devices is to implement changes to the regulatory framework that increase patient safety and promote innovation, thereby growing the life sciences sector in the UK. Alongside this, we are interested in the opportunities posed by a UK centre of excellence in regulatory science and innovation (CERSI). This was also a recommendation of the Taskforce on Innovation, Growth and Regulatory Reform report 2021, and we will continue to work with stakeholders to explore options for this.
While the activities related to the future medical devices regulations do not bring additional direct investment, they do provide a robust and positive environment in which the UK can build its reputation in all areas of life sciences, and in particular a supportive UK regulatory environment for the safe and rapid development of innovative medical devices.
In addition to the new regulatory framework, the government’s ambition to ensure the UK is a leading global hub for all aspects of life sciences is being driven by the Life Sciences Vision, published by the Office for Life Sciences in July 2021. On skills, the vision makes commitments to:
- welcoming and advocating the free flow of life sciences talent globally, underpinned by the UK’s new immigration system
- boosting the proportion of the apprenticeship levy recovered by the life sciences sector
- building links between life sciences university courses and industry
- exploring how the sector can effectively meet emerging skills demands
The vision also sets out its aims to deliver a progressive UK regulatory offer with the capacity to unleash innovation in regulatory processes. This includes a specific funding allocation to the MHRA and the National Institute for Health and Care Excellence (NICE) to develop a new access and licensing pathway for medical devices, similar to that which exists for medicines.
To further support this work, the MHRA’s future regulatory framework for medical devices will actively address the safety and availability of medical devices, and the favourability of the UK as a place to research, develop, manufacture and supply medical devices. The government has outlined intentions for requirements for a Qualified Person within the response to the MHRA’s consultation on the regulatory changes for medical devices. This proposal will require that manufacturers have available within their organisation (or in the case of small and medium-sized enterprises (SMEs), at their disposal) at least one Qualified Person with qualifications or regulatory experience that meets minimum standards that would be set out in the UK medical devices regulations in the field of medical devices and IVDs. This commitment will provide a strong incentive for increased training of regulatory professionals with expertise in medical devices.
Recommendation 7
Build international partnership through mutual recognition and reliance or assurance where this may lead to overall efficiencies while preserving safety.
Government response – accept
The MHRA delivery plan 2021 to 2023 outlines commitments to building excellent international relationships that:
- deliver high standards of patient protection
- prompt access to innovation products
- keep the UK as an attractive market for developers and manufacturers
The government sees international partnership as vital to deepen co-operation, exchange information and encourage the adoption of international standards and best practice.
The government also intends to use both certificates from the Medical Device Single Audit Program (MDSAP) and domestic assurance as alternative routes to market in the UK, which will make it easier for manufacturers to bring medical devices to the UK market while retaining strong regulatory oversight of their safety and performance.
The UK will require UK approved bodies to consider MDSAP assessments. However, adoption will be optional for manufacturers. Domestic assurance routes will allow an abridged assessment with the appropriate scrutiny, and UK approved bodies will hold the capacity to reject applications under the domestic assurance route if they do not consider the evidence provided to be sufficiently robust to undergo assessment through this route.
In 2019, the UK signed a mutual recognition agreement (MRA) with Australia that contains conditions under which each country will accept conformity assessment results from the other. This means that UK goods can be tested in the UK against Australia’s regulations, and then sold in the respective country without additional testing. This also applies for goods tested in Australia to the UK regulations.
We are in ongoing discussions to expand existing MRAs to include medical devices, and to build new MRAs that provide for a mutual acceptance of conformity assessment results with other countries. The UK-Canada Trade Continuity Agreement highlighted that the medical devices sector is a priority for mutual recognition of the acceptance of conformity assessment results, and further expansion will be explored in the future.
Through bilateral engagement, the government is encouraging other countries to join and adhere to multilateral medical device regulatory forums, which produce best practice guidelines for regulators and reduce the discrepancies between regulatory systems. Through further international collaboration and regulatory harmonisation, we will promote an efficient and effective global market for placing medical devices on the market, which is responsive to emerging challenges while maximising patient safety.
Using medical devices as a template to help enable regulatory innovation that improves patient safety, system efficiency and UK growth
Recommendation 8
Identify and resource areas where regulatory innovation within the medical device sector may attract inward investment and growth.
Government response – accept
The MHRA’s future regulatory framework outlines plans to create new routes to market to support innovation in medical devices. This will ensure the UK remains an excellent place to launch new medical devices and avoid repeat assessments, while maintaining robust safety standards.
Following the UK’s departure from the European Union, the MHRA now has direct responsibility for the regulation of medical devices in the UK. One of the freedoms that come with this is the ability to reform medical device regulation to ensure it better fits software and AI.
The regulation of AIaMD is an area where regulatory innovation will attract inward growth and investment. The MHRA has an opportunity to become a global leader in the regulation of AIaMD and to demonstrate the MHRA’s capacity to support responsible innovation while minimising risk to patients and the public.
The MHRA has embarked upon an ambitious Software and AIaMD Change Programme to help achieve this, reforming medical devices regulation as it applies to software and AI, and introducing new guidance and support packages. This work programme will deliver bold change to bring a high degree of protection for patients and the public, while also making sure that the UK is the home of responsible innovation for medical device software.
As mentioned in the response to recommendation 6 above, the MHRA and NICE also have plans to establish a pathway for medical devices that is similar to the Innovative Licensing Access Pathway that is currently in place for medicines. This pathway will allow for increased MHRA and NICE support for products that meet a critical unmet need, thereby attracting growth and investment in this sector.
To further explore pathways for innovative devices, the government is working to explore options to increase access and adoption of medical technologies. This will accelerate the work already in motion as part of the Life Sciences Vision, the MHRA’s new regulatory framework and the upcoming MedTech strategy by finding opportunities to increase market access and adoption of medical technology. As a result, we will seek to increase investment by making the UK a more attractive regulatory environment for companies bringing new products to market.
Recommendation 9
Develop a UK patient safety database that collects key details of all medical devices and monitors patient safety and wellbeing moving forward.
Recommendation 9A
Strengthen existing safety reporting through digital tools and the use of comprehensive data collection from health systems, patients and carers to a central MHRA-held UK patient safety database.
Recommendation 9B
When medical devices are used, their unique device identifier (UDI) should be recorded as standard within a patient’s health record, and this should be returned to a central MHRA-led UK patient safety database.
Government response – accept in principle
The MHRA has recently launched improvements to its Yellow Card scheme, which collects and monitors information from the public on suspected safety concerns involving healthcare products, including medical devices. The scheme helps the MHRA monitor the safety of medical devices along with all healthcare products in the UK, and reports through the scheme are used to help the MHRA identify any trends in the safety or efficacy of a medical device and take action accordingly.
The scheme’s improved website went live on 7 February 2022 with new functionality for reporters, such as a single reporting form, and further enhancements to the reporting journey will be made in coming months. One technology platform for incident management and signal detection across medicines and devices is being developed for the MHRA’s use, which will allow improved analysis and faster signal detection, and enable the MHRA to proactively respond to safety concerns.
Another key focus of current work in improving the safety of patients using medical devices is in the area of implantable devices. Following several high-profile failures of implanted medical devices, the government has recognised the need for greater, systematic information to be captured and shared on these interventions. The need for better data on patient outcomes and device traceability was highlighted by the Independent Medicines and Medical Devices Safety (IMMDS) Review, which recommended a system be established that would capture key information on implanted devices at the time of the operation and linked to specifically created registers to research and audit the outcomes both in terms of device safety and patient-reported outcome measures. The government accepted that recommendation in its response to the IMMDS Review on 21 July 2021.
In 2021 to 2022, a scoping exercise was undertaken that provided substantial learnings for how best to deliver on these traceability and patient outcome objectives. The government sets out more detail on how this work is progressing in the IMMDS implementation update. It is envisaged that the data collected as part of this programme will be shared with the MHRA for post-market surveillance purposes and therefore we do not accept that part of the recommendation.
Building resilience and preparing for future threats
Recommendation 10
Pandemic preparedness should include fast-track evaluation of new IVDs.
Government response – accept
The MHRA’s future regulatory framework intends to reform IVD regulation to update classification and include an extended patient risk review, recognising the central role that diagnostic devices have played in our response to the COVID-19 pandemic.
While stronger regulation is needed, the diagnostics sector needs to be sufficiently responsive. The 100 Days Mission to Respond to Future Pandemic Threats (June 2021), announced at the G7 Summit in Cornwall – proposed to build a framework for fast pandemic threat response and related work – will be taken forward through this strand. This framework will include plans for enabling prioritisation of clinical trials for diagnostic products (as well as vaccines and therapeutics) and faster approvals from regulators.
The 100 Days Mission for diagnostics, therapeutics and vaccines was welcomed by G7 and G20 leaders respectively. The first implementation report was published by the G7 Chief Scientific Advisers in December 2021, which outlined progress to date and a roadmap for achieving the mission by 2026. As part of the 100 Days Mission, the MHRA and the US FDA will collaborate with their G7 counterparts to implement proposals to streamline regulatory processes over 2022 to 2026. This could include a streamlined process for new product applications, and will explore the possibility of reciprocal agreements on regulatory approval to negate the need for the same product to be approved in multiple jurisdictions.
The lessons from the COVID-19 pandemic are being considered, and the government intends to enable a fast-track route for IVDs, as part of the ambition outlined in the 100 Days Mission, that is proportionate and workable for industry should future threats emerge, while maintaining quality and performance.
Recommendation 11
Reporting of diagnostic tests should be transparent and standardised.
Government response – accept in principle
The MHRA’s future regulatory framework intends to address the recommendation to increase the level of scrutiny applied to IVD devices. The new framework for IVDs will amend the classification rules to increase the level of scrutiny applied to IVDs. This will mean a higher proportion of IVDs will undergo an assessment by a UK approved body prior to being placed on the UK market. The proposed regulatory changes will take into account the intended purpose of the medical device and will reflect relevant international systems of regulation, driving greater patient safety.
The new regulatory framework will bring significant improvements in patient safety and ensure more robust pre and post-market requirements are introduced for IVDs, aligning with the international set of standards set by the IMDRF, rather than the Standards for Reporting of Diagnostic Accuracy Studies Framework. This will provide clarity and ensure that performance studies for IVDs are carried out in a consistent way. The government aims to set out in detail the specific requirements for any performance study, and to publish detailed guidance to accompany the regulatory requirements.
