As one of the fastest-growing segments of the healthcare sector, it comes as no surprise that healthtech regulation in the UK is undergoing significant change.
Key factors fuelling this overhaul include:
- The need to reform the UK regulatory regime following Brexit
- The realisation during the COVID-19 pandemic that industry and government can, and should, work together more effectively to bring products to market faster
- The subsequent publication and government-led push to implement the Life Sciences Vision
It is notable that much of the law and regulation that applies to healthcare technology – with some exceptions noted below – whether for new tech-driven medical devices, medicines solutions, or other healthcare services, has not always developed with tech in mind and applies to traditional services just as it does to newer, tech-based solutions.
So, while we talk of healthtech regulation, it is often the case that there is no regulation as such, but rather new and existing law that relates to medical devices, medicines, and other healthcare solutions that will apply irrespective of how those things are provided.
This briefing should be of particular interest to Health Tech developers and investors that may be newer to the sector and are familiarising themselves with the legal frameworks that apply.
Making the transition
The timing of the UK’s exit from the EU has meant that major regulatory reform implemented in the EU (and which the UK played a key role in shaping) does not apply in the UK.
This includes key areas of healthtech regulation such as:
- Clinical trials (where the new Clinical Trials Regulation has applied in the EU from January 2022, but the UK regime is still based on the old 2001 EU Directive)
- Medical devices regulation, (where the new Medical Devices Regulations has applied in the EU since May 2021, while the UK regime is still largely based on the Medical Devices Regulation 2002
As a result of this, a number of consultations have been held by UK regulators in these areas, with sweeping reforms proposed in government responses published this year.
Following the global pandemic, a prevailing view within the life sciences sector is that the UK has a unique opportunity to build on the success of the vaccine programme and create a centre of excellence for companies looking to bring medicines and medical devices to market.
The Government supported that belief by publishing its Life Sciences Vision in July 2021 and following this up with a series of:
- Funding announcements aimed at supporting innovation in Health Tech (for example, the recent £30m NHS med tech fund and Spring Budget commitments)
- Publications setting out practical recommendations for creating a regulatory environment which fosters innovation (for example, the recommendations made by the UK Chief Scientific Advisor in the report on Pro-Innovation Regulation of Technologies in Life Sciences which were universally accepted by the Government, and the Life Sciences Council’s joint statement on medical devices regulatory reform)
If there is to be a Labour government following the next general election, Labour has confirmed it will align its life sciences strategy to the Life Sciences Vision.
Medical device regulation
The government body responsible for regulating medical devices, the Medicines & Healthcare products Regulation Agency (MHRA), has laid out a suite of legislative and regulatory changes which are hoped will maintain the UK's position as a lead market competitor in the medical devices industry.
Earlier this year, the MHRA updated its guidance on the implementation of the future medical devices regulations to confirm the intention for the ‘core aspects’ of the UK regulations to apply from July 2025.
The MHRA is targeting a proportionate, phased implementation to allow for a smooth transition and reduce disruption.
While much of the new medical device regulatory framework is yet to be given a definitive form, the government response to the MHRA’s 2021 consultation established five key pillars which are intended to support the reforms:
- Strengthen the MHRA’s power to act to keep patients safe
- Make the UK a focus of innovation
- Address health inequalities and mitigate biases throughout medical device product lifecycles
- Establish proportionate regulation which supports businesses through access routes that build on synergies with EU and global standards
- Set world-leading standards through the new UKCA mark
The aim remains to better align with international best practice where this is of benefit to UK patients and diverging only where advantageous to do so.
The proposals bring the UK regime in line with the requirements of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), and refer to international definitions and guidance from the International Medical Device Regulators Forum (IMDRF).
The UK Government has introduced legislation to allow valid EU CE marked medical devices to continue to be placed on the market in Great Britain.
The Medical Devices (Amendment) (Great Britain) Regulations 2023, which came into force on 30 June this year, set out new transitional periods in which valid CE-marked medical devices will continue to be accepted for sale in Great Britain according to the type of device, as follows:
- 30 June 2028: end of transition period for general medical devices compliant with the old EU medical devices directive or EU active implantable medical devices directive
- 30 June 2030: end of transition period for in vitro diagnostic (IVDs) medical devices complaint with the EU IVD medical devices directive
- 30 June 2030: end of transition period for general medical devices compliant with the EU medical devices regulation
Companies should note that the above transitional periods allow manufacturers of medical devices to continue to rely on expired EU Medical Device Directive certificates to place medical devices on the Great Britain market where they have been deemed valid under the transitional arrangements relating to the EU Medical Devices Regulations 2002.
Innovative devices access pathway
The Innovative Devices Access Pathway (IDAP) is a pilot for a regulated support service designed to improve patient access to cutting-edge technology, facilitate the development of innovative technologies, and support the Government’s strategy of embracing innovation.
The IDAP will be collaboratively operated by the MHRA, the National Institute for Health and Care Excellence (NICE), Health Technology Wales, and the Scottish Health Technology Group and it is hoped that it will ‘bring innovative technologies and solutions to the forefront of the NHS’.
The IDAP is open to UK and international developers with new health technology solutions and the primary aim is to ‘take uncertainty out of the route to access’, bringing innovative technologies to patients that can transform health outcomes.
The IDAP will help innovators generate evidence that meets the needs for the UKCA marking process and consider the needs of the health technology assessment process early in the development pathway. IDAP will also offer post-market access support.
The IDAP was launched in September 2023 and developers can register interest here.
The recently-published draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023 will establish a new regime for post-market surveillance of medical devices in the UK and is expected to come into force mid-2024.
The draft regulations outline what a post-market surveillance plan should cover (including data collection and processing obligations, and complaint investigation), as well as requiring that a proportionate post-market surveillance system is implemented for each medical device placed on the Great Britain market.
The draft 2023 regulations broadly follow the approaches taken by the comparable EU legislation, the Medical Device Regulations and the In Vitro Diagnostic Medical Device Regulations.
At a high level, both require implementation of a post-market surveillance plan per device placed on the market ‘for the purposes of identifying any need to apply corrective or preventive actions’.
However, there are some differences. For example, under the EU regime, medical device manufacturers are not required to report serious incidents where that serious incident is an expected side-effect that has been appropriately documented, but this exception has not been replicated in the draft UK legislation.
Software and AI as medical devices
For an overview of software and AI regulation in the UK, please refer to the first article in our Health Tech Series here.
The article outlines various key features of the UK’s approach to regulating software and AI as medical devices, such as the White Paper on the UK AI framework and its interaction with the healthcare sector, and draws comparisons with the approach taken in the EU.
Additionally, it provides some practical steps for both developers and users of Health Tech AI systems to take as regulation in this area develops.
At the beginning of July, the MHRA published its 2023-2026 Corporate Plan, which highlights the importance of introducing new legislation and guidance on clinical trials in the UK to help provide the ‘stable and predictable regulatory environment that companies require’.
The intention is that by March 2026, the MHRA will implement a revised regulatory framework for clinical trials.
UK regulatory backdrop
Despite the EU’s Clinical Trials Regulation (536/2014) entering into force in the EU in January 2022 (following significant input from the MHRA), due to the timing of Brexit, the previous 2001 EU Directive (2001/20/EC) remains the current primary source for clinical trials regulation in the UK.
In March 2023, the MHRA published its response on proposals for changes to the law governing clinical trials, namely the Medicines for Human Use (Clinical Trials) Regulations 2004.
Responses demonstrated strong support to update and improve the legislation governing clinical trials, with most respondents agreeing that patient safety should remain the focus of the legislation, but with a more-flexible and risk-proportionate approach to decision-making.
In line with responses to other recent consultations, the MHRA is looking to align with international standards rather than be limited by alignment with the EU.
It is hoped that the implementation of the proposals will make it easier and more efficient to run trials in the UK, enabling greater patient access to new, safe, and life-changing treatments, while making the UK an attractive place for trials.
We have previously outlined a number of the reform proposals here.
New notification scheme for lowest-risk clinical trials
The first reform was introduced in October 2023, with the MHRA announcing a new streamlined notification scheme for the lowest-risk clinical trials, which aims to halve the time to receive an approval decision.
Under the scheme, initial applications for the lowest-risk Phase 3 and 4 trials will be processed by the MHRA within 14 days instead of the statutory 30 days, provided the sponsor can demonstrate the trial meets the MHRA’s criteria, including by confirming there are no known safety issues with the medicine being investigated.
The MHRA anticipates that 20% of initial clinical trial applications in the UK will be eligible for the fast-track process.
The Lord O’Shaughnessy Review
After the March 2023 consultation response, an independent report was published in May 2023 following the Lord O’Shaughnessy review into commercial clinical trials.
And the Government’s response to the review was published alongside the independent report.
The report outlined 27 recommendations on ‘how commercial clinical trials can help the life sciences sector unlock UK health, growth and investment opportunities’.
The Government’s response agreed with each recommendation, noting that clinical research is a ‘key driver’ of growth in the UK life sciences sector and that improving clinical trials regulation will allow the UK population ‘to access ground-breaking treatments that can dramatically improve standards of care’.
On 30 June 2023, the NHS Health Research Authority (“NHS HRA”) published its comments on the review, welcoming the Government’s response.
The NHS HRA noted that it is collaborating with a number of organisations across UK clinical research to deliver recognised outcomes, such as achieving a 60-day turnaround time for regulatory approvals.
The NHS HRA also confirmed that it is ‘supporting implementation of enhanced National Contract Value Review’.
The NCVR was established in the Future of Clinical Research Delivery: 2021 to 2022 implementation plan in order to streamline establishing contracts that set up commercial trials.
The fourth recommendation of the Lord O’Shaughnessy review was that a ‘comprehensive and mandatory national approach to costing and contracting should be developed and instigated, in partnership with industry’, via a radical expansion of the NCVR, which the UK government has agreed with.
Timescales on this revised NCVR are ambitious, with the Government reinforcing its commitment to a mandatory national approach to costing and contracting, led by NHSE England, with an enhanced service to be delivered from October 2023.
An integral part of the proposed regulatory reforms is ensuring the UK remains an attractive place to do business in a global life sciences market.
In June 2023, the MHRA announced new recognition routes for medicines approved by regulators in Australia, Canada, the EU, Japan, Switzerland, Singapore, and the US. This will replace the EC Decision Reliance Procedure which temporarily allows the MHRA to rely on a decision taken by the European Medicines Agency when granting marketing authorisations (MAs) for Great Britain.
The MHRA has said that new recognition routes are ‘focused on providing UK patients faster access to the absolute best, most-cutting-edge, and safest medical treatments’.
Pursuant to this announcement, MAs may be granted via two routes:
- The MHRA’s own assessment and approval procedure
- International recognition routes which allow the MHRA to rely on approvals from trusted regulatory partners around the globe
The MHRA has recently-published guidance which confirms that the new international recognition procedures will be available to MA holders from 1 January 2024.
The guidance specifies the various recognised regulatory authorities in different countries from whom applicants must have authorisation. It also outlines two recognition timetables: (i) 60 days for simpler applications where a recognised regulator’s approval was granted within the previous two years; and (ii) 110 days for more-complex applications where a recognised regulator’s approval was granted within the previous 10 years.
We have outlined this guidance in greater detail here.
The extent to which the UK pursues international conformity in the context of healthtech regulation generally, and medical devices in particular, remains to be fully determined. However, what is clear is that the Government’s approach to regulatory review in this area is purposive – to drive investment, foster innovation, and improve patient outcomes.