When first putting together this issue of Med-Tech Innovation News, my Twitter (no Elon, I’m not calling it X) feed in the early days of January lit up with government cabinet members celebrating the great opportunity that awaits businesses in the UK joining the Horizon Programme. Sorry, re-joining.

I had earlier said in a piece on the website that it was a good move from government for the UK to be back in the Horizon Programme – a grown up move following several years of populist, childish squabbling. Yet it stuck in the craw a little when a substantial number of those who advocated for Britain’s withdrawal from the European Union, subsequently shifting the goalposts to claim a mandate to withdraw from any initiative or institution that had any variation of the word “Europe” in the title – were those celebrating this news.

It serves as a reminder of the uncertainty and lost time and talent that has been a signature of recent years because of playground politics. Speaking of which, it is an election year in the UK, with opinion polls suggesting the public will be voting for a change in government. If that is the case, one would hope that an ejection of the incumbents will see a return to sanity, allowing industry, and businesses such as in this sector to have a more certain environment to operate in and make it easier to trade with neighbouring nations.

That’s not to say a change in government will be the silver bullet to all the challenges facing manufacturers and other businesses involved in medical technology. There are challenging economic conditions still being faced, the manufacturing outlook in the UK is not exactly optimistic as one report indicated the sector shrank for the 17^th consecutive month with optimism hitting a 12-month low at the start of January – and on a wider scale, economic statistics suggests the UK economy entered recession towards the end of last year.

On a separate note, this will be the last time I will be adorning these pages, so apologies to those who miss my musings, but after the best part of four years editing this title, and five-and-a-half years at Rapid News, it’s time for a change from writing about all things medical technology in an editorial capacity.

It has been a great pleasure covering this industry. I knew close to absolutely nothing on Day One walking into this job – some of you may suggest I don’t know an awful lot now – but it has been an eye opener covering this industry during one of the most tumultuous times in human history with a pandemic and seeing how much a force for good the sector can be. It’s been, and still is, a really exciting time to be a part of it.

I’m sure the next editor will have loads of fun with you all, and I’m very excited for the journey they will be going on with you.

For those wondering if I’ll still be involved in medical technology. Yes, in a way, on the other side of the fence! You might well see me at Med-Tech Innovation Expo 2024. So, this might not be goodbye, just au revoir.

It was set up as a quango, which means it is funded by taxpayers, but not directly controlled by central government. As the prime minister has said in recent days, the same jobs were being done by similar departments in both NHSE and the Department for Health and Social Care (DHSC), so the plans will aim to streamline functions.

The prime minister has said that abolishing the body would “cut red tape” and bring management of the NHS “back into democratic control”, also adding that it would allow for a refocus on cutting waiting times at hospitals.

Speaking about the reported 9,000 jobs that will be lost due to the plans, Health Secretary Wes Streeting told Sky News’ Trevor Phillips: “[It] will be an anxious time for them… there’s no way of sugarcoating it. But we will be treating people with care and respect and the fairness that they are owned through this process.”

Med-Tech Insights heard from experts and members of the MedTech industry with their reaction to the news:

Chris Whitehouse, a political consultant and expert on MedTech policy at Whitehouse Communications said:

“The move is born of the frustration of government ministers that whilst they, in the eyes of the voters, are accountable for long waiting times, poor productivity, plummeting staff morale and poor health outcomes, ministers have not been able to exercise sufficient political control to force through change at the pace that will be necessary for voters to see real improvements delivered at sufficient pace.

“Wes Streeting’s announcement makes it clear that work must begin immediately to return many of NHS England’s current functions to the Government’s Department of Health and Social Care.

“A longer-term programme of work will deliver the changes to bring NHS England back into the department, while maintaining a ‘laser-like focus on the government’s priorities to cut waiting times and responsibly manage finances’. It will also realise the ‘untapped potential of the NHS as a single payer system, using its centralised model to procure cutting-edge technology more rapidly, get a better deal for taxpayers on procurement and work more closely with the life sciences sector to develop the treatments of the future’.

“The devil will be in the detail of future structures and priorities, but given the challenges facing government in terms of waiting lists, patient outcomes, and out of control spending, there’s every chance that the changes bode well for the MedTech sector, provided it continues to engage with government to promote the role it can play in helping the government deliver on its objectives.”

Sarah Woolnough, Chief Executive of The King’s Fund, said:

“The announcement lands on the same day that NHS stats show people continue to wait days in A&E and many patients remain stuck in hospital beds despite being well enough to leave. The most important question is how will the abolition of NHS England make it easier for people to get a GP appointment, shorten waits for planned care, and improve people’s health. That hasn’t yet been set out – ministers will need to explain how the prize will be worth the price.

“It is absolutely right that democratically elected politicians must have clear oversight of how the NHS delivers for patients and spends hundreds of billions of taxpayer money. It is also reasonable to want to deliver better value by reducing duplication and waste between two national bodies where they are performing a similar role. It is true that over its just over a decade of existence, NHS England has been asked to take on a lot more additional power, functions, and therefore staff, than it was originally designed to do.

“Having now made the decision to abolish NHS England, and whilst we still wait for the publication of the NHS 10-year plan, the government must be clear why this significant structural change at this time is necessary, and how its fits into their wider plans. The potential costs savings would be minimal in the context of the entire NHS budget, and so they must ensure that the changes produce the improved effectiveness which is sought by making this change.  As with previous NHS restructures, structural change comes with significant opportunity cost, with staff who would otherwise be spending their time trying to improve productivity, ensure safety, and get the best outcomes for patients, now worrying about whether they will have a job.”

Kate Davies, public procurement associate director in the life sciences and healthcare team at Osborne Clarke: 

“Over the next two years, existing contracts between NHS England and its suppliers will need to be novated to the Department of Health. For new contracts that would have been procured by NHS England under the Procurement Act 2023 (such as for goods and non-healthcare services), the Department of Health can procure those contracts under the same legislation. Suppliers will notice some changes in what and how contracts are procured.

“In particular, we expect to see more centralisation of approach, but fundamentally the same legal principles will apply. However, in relation to healthcare services that would have been procured by NHS England under the NHS Provider Selection Regime, the legislation does not currently allow the Department of Health to award contracts under that legislation. The government will need to amend the legislation to allow the Department of Health to have this power, and until then, we expect NHS England to continue procuring essential contracts under the PSR until the amendments can be effected.”

Peter Rudd-Clarke, regulatory and litigation partner in the life sciences and healthcare team at Osborne Clarke:

“Manufacturers of medical devices and pharmaceuticals will want to see how these reforms dovetail with the work the government is doing on its 10-year health plan for the NHS. The government has stated that its focus will be on reforming the current healthcare model by moving from analogue to digital systems, and by putting an emphasis on prevention of sickness.

“NHS England is being scrapped soon after the government’s creation of the Regulatory Innovation Office (RIO). RIO was launched in October 2024 and is intended to support the regulatory system in bringing innovative products and services to market more swiftly, including digital health products, medicines and services.

“Manufacturers will hope that by integrating NHS England’s functions into the DHSC, the healthcare system will be able to provide greater political support, and public money, for the adoption of innovative life sciences products that support the aims of RIO and the government. These aims are expected to receive further impetus when new pre-market medical device regulations, and associated MHRA guidance, is brought in during 2025 and 2026.”

Dr Sonia Szamocki, founder and CEO of 32Co, says:

“As someone who has worked as a front line doctor, delivered healthcare transformation projects as a management consultant, and now building a company in the dental sector – I have seen every angle, and re-organisation on this scale is incredibly challenging. I’d caution anyone who believes this will result in overnight change.”

Matt Skinner, CEO of CareCity said:

“The announcement of the planned abolishment of NHS England to help ‘put health service back into democratic control’ represents a shift in the UK’s healthcare system strategy.

“However, simply ploughing any savings from reducing bureaucracy into our existing frontline will only be a temporary fix to a much more permanent problem. A focus and investment into prevention is required to realise any significant benefit, to both the economy and our population, from these savings. Only by tackling health problems further upstream (and working closely with communities and social care) can we stem the tide which is already overwhelming services and delivering worse outcomes for people.

“This is a once in a generation opportunity to divert significant funds to local, on the ground prevention which can improve health outcomes, reduce healthcare costs, and improve quality of life. It should be an opportunity to embrace and properly fund new integrated ways of working, innovations and design led approaches to health and care that work with and for our communities. I hope we also see investment in meaningful digital and tech approaches to prevention, leveraging the cost effective potential in early detection programs, assistive technologies and remote monitoring.”

In a significant stride towards enhancing global health and innovation, the United Kingdom and India have signed a landmark Memorandum of Understanding (MoU) to bolster collaboration in the health and life sciences sectors. This partnership underscores the strong strategic ties between the two nations and aims to boost shared expertise and innovation in MedTech and healthcare.

The MoU, signed by representatives from both governments, establishes a framework for cooperation in health technology and innovation. It is designed to facilitate the exchange of knowledge and expertise, ultimately improving health outcomes and advancing medical research and development.

The agreement aims to enhance partnerships in health technology and innovation, leveraging the strengths of both nations to address global health challenges. Both countries will share information on health-related issues, promoting efficiency and effectiveness in their respective health systems.

In India, the Ministry of Health and Family Welfare will lead the efforts, while in the UK, the Department of Health and Social Care, along with devolved health authorities, will spearhead the initiatives.

The UK government argues that the MoU is a testament to the commitment of both nations to work together towards a healthier future and claims that by combining their resources and expertise, the UK and India will make significant advancements in health and life sciences, benefiting not only their own populations but also contributing to global health improvements.

In late 2022, the EU and UK announced proposed delays to the implementation of new medical device regimes in both markets, setting new timelines for compliance by medical device manufacturers.

The European Union Medical Device Regulation (EU MDR) was first enacted in 2017. At the time, the implementation periods looked ambitious but achievable. The new law was intended to apply in the United Kingdom, and the UK regulators had played a key role in the drafting of the EU MDR.

In practice, implementation in both the European Union and United Kingdom was severely affected by a number of converging factors, including Brexit, COVID-19, supply chain issues, and a lack of designated notified bodies to certify devices. These issues reached a head in 2022.

In July 2022, MedTech Europe, the European trade association for medical technology reported that, based on a survey it had taken of the industry, EU MDR certificates had not been issued for more than 85% of devices previously certified under the old law, and more than 50% of survey respondents indicated that portfolio reductions were planned. Towards the end of 2022, there were multiple calls for an extension to the implementation timetable. In December 2022, the European Commission announced that changes would be made to the implementation transition of the EU MDR. The formal proposal for the regulation was issued on 6 January 2023 (the Commission Proposal).

As a result of Brexit, UK law was changed to allow a transitional period for the placing of EU marked devices in the Great Britain market and to introduce a new certification for medical devices in the market by 2023, known as the UK Conformity Assessed (UKCA) mark. In June 2022, the UK government issued proposals to change the UK medical device legislation (the New UK MDR). These proposals were broadly similar to the changes in the EU MDR and were expected to be published in Autumn 2022. The publication of the draft New UK MDR was delayed, and the implementation of the UKCA mark has been affected by a shortage of approval bodies. These cumulative challenges led to calls by the industry for an extension to the current transition period and a delay to the new law.

In late 2022, the UK Government announced delays to the transition period and a new timeline for the New UK MDR. The delays have not yet been formalised in law, but it has been proposed that the new law will not come into force until July 2024, so there will be a longer transitional period in which EU marked devices (under both the old EU and new EU law) will continue to be allowed to be placed on the Great Britain market.

The proposed new EU transition periods 

The 6 January Commission Proposal points out that, despite considerable progress over the past years, the overall capacity of notified bodies remains insufficient to carry out the tasks required in the conformity assessment procedures. In addition, many manufacturers are not adequately prepared to meet the strengthened requirements of the EU MDR by the end of the current transition periods. The Commission concludes that these circumstances threaten the availability of medical devices on the EU market.

The Commission Proposal aims to resolve these issues. It provides, inter alia, extensions to the transition periods stipulated in Article 120.3 of the EU MDR. In particular, the Commission Proposal contains the following suggested amendments to the EU MDR and In Vitro Diagnostics Regulation (IVDR):

• • Longer transition periods that vary based on the respective device’s risk classification:

• • High risk devices (Class III and Class IIb) will be required to conform to the EU MDR by 2027 at the latest.

• • Medium and low risk devices (Class IIa and Class I) will be required to conform to the MDR by 2028 at the latest.

• • To benefit from the extended transition periods, the manufacturer must have commenced the steps necessary for the device’s compliance with the EU MDR before the relevant deadline.

• • Certain limitations with regard to the benefit from the transitional periods provided in the EU MDR will continue to apply. In particular, a device may not benefit from the transition period if it has undergone significant changes in design or intended purpose, or if it presents an unacceptable risk to health or safety.

• • By 26 May 2024, manufacturers must have put in place a quality management system in accordance with Article 10, paragraph 9 of the EU MDR. This condition aims to ensure that manufacturers gradually move towards full compliance with the EU MDR requirements.

• • The extension of the transition period is complemented by an extension of the validity of certificates issued under the previous Council Directives 90/385/EEC and 93/42/EEC.

• • Subject to certain conditions, the validity of certificates that have already expired since 26 May 2021 shall be extended.

• • The sell-off date currently provided for in Article 120, paragraph 4 of the EU MDR shall be removed altogether. As a result, devices previously placed on the European Economic Area (EEA) market on the basis of CE certificates issued under the former regime may in theory remain on the EEA market indefinitely.

• • The same applies to in vitro diagnostics: the current sell-off dates in Article 110, paragraph 4 of the IVDR—25 May 2025 to 26 May 2028—are supposed to be deleted. As a result, devices placed on the market before the end of the transition period laid down in Article 110, paragraph 3 of the IVDR can be made available on the market without time restrictions.

The proposal still needs to move through the EU legislative procedure, during which it may still be amended. In particular, the EU Parliament and Council of Ministers must approve the changes. Given the urgency, this is proposed to be undertaken under an accelerated procedure to ensure that the proposed adjustments eliminate any risk of shortages in the short term and ensure access for patients most in need of these products.

The new UK transition periods

The current UK medical device legislation transitional provisions, which were adopted at the time of Brexit, allow for the recognition in Great Britain of CE marked devices and certificates issued by EU-recognised Notified Bodies until June 2023. From 1 July 2023, the law states that all medical devices placed on the GB market must have a UKCA mark. This position is still reflected in the current Medicines and Healthcare products Regulatory Agency (MHRA) website guidance. In October 2022, the MHRA proposed delays to the June 2023 deadline, but, at the time of going to press, the Agency has not yet updated the guidance on its website.

The October 2022 proposals need to be read alongside the UK Government’s consultation on the New UK MDR, which was initially meant to come into force on 1 July 2023. The New UK MDR proposed transition periods that would permit EU originating, CE marked devices to continue to be placed on the Great Britain market.

According to the MHRA’s October 2022 proposals,

• • CE marks will continue to be accepted in GB market until July 2024.

• • The requirement to obtain a UKCA mark will be delayed until July 2024.

• • The New UK MDR is expected to be published in Spring 2023, and come into effect from July 2024.

Assuming the New UK MDR is now enacted in line with these proposals, it appears that the original, already generous transition periods will be extended by a further year.

UK transition arrangements

The original transition timelines for the New UK MDR allow for the following transitional arrangements.

For UKCA marked devices, at a minimum, products can be placed on the market until either the relevant certificate expires, or for three years (in the case of general medical devices) or five years (in the case of in vitro diagnostics or IVDs), whichever is sooner.

In relation to CE marked devices (under the EU MDR or EU IVDR), products can continue to be placed on the market until either the certificate expires or for five years after the new regulations take effect, whichever is sooner.

If the MHRA consultation proposals are implemented in the New UK MDR (due to be confirmed in the coming months) and the October 2022 proposals are enacted, depending on the device’s certificate date and basis, the latest dates by which legacy devices may be placed on the Great Britain market are as follows:

• • June 2027 for UKCA devices (previously June 2026)

• • June 2027 for EU MDD devices (previously June 2026)

• • June 2029 for EU IVDD devices (previously June 2028)

• • June 2029 for EU IVDR and MDR devices (previously June 2028).

The dates in parentheses also show the initial transition periods proposed under the UK MDR.

There are a lot of “ifs and buts” in these timelines. The new law has not yet been issued in draft form and, somewhat confusingly, at the time of going to press the MHRA guidance continues to reflect the current law, still specifying June 2023 as the deadline for transition. It is also unclear how the October 2022 proposals will affect the transition time lines. The draft of the New UK MDR is due to be published in early 2023 and will be eagerly awaited by the medical device market.

Many questions therefore remain unanswered and manufacturers looking to certify new devices before June 2023 have several options to consider.

There is, however, one piece of good news for manufacturers who place their devices on the EU market. It appears that these certificates will continue to be accepted in the United Kingdom for a longer time period and that this will apply for certificates that are extended under the Commission Proposal. Given that many EU certificates under the old EU law were due to expire in 2024, if the October 2022 proposals are enacted, this may be welcome relief for manufacturers. This means that manufacturers with legacy devices under the old EU law may benefit from certification under the current UK law, with a UKCA mark, given this regime remains the same as the old EU law.

Good news in Great Britain for international manufacturers 

In a statement issued on 16 December 2022, the UK Government signalled its intention to publish new proposals on international recognition routes and routes for innovation and system capacity in February 2023. These announcements are likely to set out proposals on e-labelling and the recognition of other jurisdictions, such as the United States.

What ITH Group Does

ITH Group isn’t your typical pharmaceutical company. Founded in 2008, the firm specializes in aseptic pharmaceutical compounding – essentially creating custom injectable medications for patients whose medical needs can’t be met by standard treatments available on pharmacy shelves.

The company operates facilities in London and has built market-leading positions in three key areas: chemotherapy treatments, total parenteral nutrition (specialized feeding solutions), and central intravenous additive services. These services are particularly crucial for both adult patients and neonates who require precisely tailored medication dosages and formulations.

What makes ITH particularly valuable is its dual-market approach. The company serves both NHS patients and private healthcare customers, giving it exposure to the stability of the UK’s public healthcare system while also benefiting from private market growth.

Why This Deal Makes Sense for HIG Capital

ITH Group fits perfectly into HIG Capital’s healthcare investment thesis. The company operates in what industry insiders call an “inherently undersupplied market” – there simply aren’t enough providers offering these specialized compounding services relative to demand.

“The Company’s track record of reliably providing compounded pharmaceuticals to NHS and private customers in an inherently undersupplied market, combined with H.I.G.’s history of supporting capacity expansion in its portfolio companies, underpins an exciting next chapter for ITH,” said John Harper, managing director and head of H.I.G.’s Europe Lower Middle Market LBO team.

The acquisition also demonstrates HIG Capital’s ability to identify businesses that provide essential services with high barriers to entry. Aseptic pharmaceutical compounding requires specialized facilities, regulatory compliance, and technical expertise – factors that limit competition while ensuring steady demand.

Management Continuity and Growth Plans

One telling sign of confidence in the deal? ITH’s founding team is staying put. Adam Bloom and Karen Hamling, who built the company from the ground up, will continue as CEO and COO respectively. This management continuity typically signals that the acquisition is about growth acceleration rather than operational overhaul.

“Since our founding in 2008, ITH has consistently grown by investing in our people and enhancing the services we provide to patients,” Bloom explained. “Today, we are proud to be a leading provider of compounding services in the UK, supporting both the NHS and private healthcare sectors.”

HIG Capital plans to support ITH’s organic growth trajectory while exploring new initiatives, particularly around increasing production capacity. Given the undersupplied nature of the market, capacity expansion could unlock substantial value.

Part of a Broader June Strategy

The ITH acquisition wasn’t HIG Capital’s only move in June. The firm also brought back veteran private equity professional Antonin Marcus as a managing director in its Paris office, following his eight-year stint at Eurazeo. Marcus previously worked at HIG Capital earlier in his career and will lead middle market LBO activities in France.

“Antonin is a highly regarded private equity investor,” said Olivier Boyadjian, managing director and head of HIG Capital’s Paris office.

Meanwhile, the firm’s portfolio company Highridge Medical completed the divestiture of its EBI Bone Healing Division to Avista Healthcare Partners. HIG Capital had acquired EBI as part of Highridge’s take-private transaction in April 2024, but decided to sell the Parsippany, New Jersey-based division to allow Highridge to focus on its core spine business.

“This transaction allows us to make significant investments in Highridge’s core spine business, where we see tremendous opportunities to lead the next generation of spine care,” said Mike Gallagher, managing director at HIG Capital.

The Healthcare Play

These moves collectively illustrate HIG Capital’s healthcare investment approach: acquire specialized service providers in undersupplied markets, back experienced management teams, and provide capital for capacity expansion. ITH Group checks all these boxes while operating in a sector with predictable demand and limited competition.

With 19 offices globally and a track record spanning more than 400 companies since 1993, HIG Capital continues to demonstrate its ability to identify and scale businesses that provide essential services across multiple markets. The ITH acquisition suggests the firm sees significant opportunities in the intersection of public and private healthcare delivery – a trend likely to accelerate as healthcare systems worldwide face capacity constraints.

Ghent medtech startup PointCaré has raised nearly €1.5 million from a group of private investors. 

The company is developing OnTarget, a platform that interprets the multitude of data from various sources in operating rooms and intensive care units in real time, providing caregivers with tailored advice based on the patient and the situation. 

The startup was founded in 2022 by astrophysicist, engineering student, and anesthesiology trainee Dr Henri Van Overmeire.

Graduating cum laude in astrophysics and medicine, later specialising in anesthesiology, and also pursuing civil engineering — alongside jazz drumming and business economics training is a rather unconventional path. During Dr Van Overmeire’s time in the operating room and intensive care unit, he realized that hospitals can sometimes function in surprisingly archaic ways. This insight prompted him to consider how things could be improved.

“Critical care is integrated care. Providing care in the OR or ICU involves many components, and the effects of one aspect of treatment often have far-reaching consequences for others,” explains founder and CTO Dr Overmeire.

Critical care departments are filled with high-tech devices generating massive data streams. But data alone doesn’t save lives: the key is to take the right action based on that data. And that’s exactly where  PointCaré comes in.

Dr Overmeire contends that while new IoT technologies and communication protocols allow these devices to exchange information, without central interpretation, they contribute little to the care process. 

“Existing equipment often fails to take the individual context of each patient into account — each case, situation, and person is different.

This leads not only to diminished care quality and suboptimal treatments but also puts a heavy burden on healthcare workers, contributing to alarm fatigue and its consequences.”

The OnTarget platform gathers and centralizes all available information in real time, with full contextual awareness, and supports doctors and nurses with AI to make accurate, informed decisions based on the complete picture — factoring in as many variables as possible. 

“Beyond the clear benefits for the individual patient, by avoiding complications, we can also reduce costs in a healthcare system under immense pressure,” says CEO Veronique Pattyn.

For OnTarget, PointCaré uses not only classical NLP techniques and LLMs, but mostly their proprietary agentic AI methods, which offer full transparency in decision-making.

“Unlike many AI models today, the OnTarget platform is not a statistical ‘black box’ with hidden logic: every recommendation must be clearly traceable through a reasoning process expressed in understandable language” expanded Dr Van Overmeire.

PointCaré aims to become a benchmark in the future international healthcare landscape. A first patent application has already been submitted, and preparations for European MDR (Medical Device Regulation) approval are underway. 

With the newly secured funding, Van Overmeire plans to further develop and clinically validate the platform. By 2028, PointCaré plans to commercialise the platform internationally.

Lead image: Henri Van Overmeire, co-founder and CTO, Veronique Pattyn, co-founder and CEO, and Robbe Claeys, graph data scientist. Photo: uncredited. 

The new Post-Market Surveillance (PMS) regulations came into effect from Monday (16 June) requiring device manufacturers to actively track the safety and performance of products already in use. The reforms, which are a part of a wider effort by the Medicines and Healthcare products Regulatory Agency (MHRA) to overhaul the UK’s medical device regulatory framework, are intended to identify potential safety issues earlier and to strengthen protection for patients and the public through faster responses to incidents and emerging risks.

The reform applies to all UKCA- and CE-marked devices placed on the market in Great Britain after 16 June. This includes in vitro diagnostic devices, active implantable medical devices as well as other technologies used in a clinical setting and within the home.

Manufacturers are now required to collect and assess real-world safety and performance data; report serious incidents to the MHRA within 15 days (previously 30); submit essential communications on patient safety (Field Safety Notices) to the MHRA for review before sharing with users; and provide PMS Reports or Periodic Safety Update Reports (PSUR) within three days of request. For higher risk devices, UK approved bodies will monitor these reports ensuring these products receive a higher level of scrutiny.

“As innovation in health technologies accelerates, regulation must keep pace,” Lawrence Tallon, chief executive of the MHRA said. “Today’s reform is a critical step in ensuring safety standards evolve alongside this progress. By strengthening oversight of device once they’re in use and setting clearer expectations for manufacturers, these new regulations provide a robust framework for identifying risks earlier and responding to protect patients.

“This represents an important milestone in our work in building a modern, responsive regulatory system—one that puts patient safety first, while also supporting innovation in life sciences and medical technologies across the UK.”

The introduction of new data analysis reporting requirements will apply to all medical devices but are particularly valuable for improving oversight of lower-risk devices, MHRA adds. These rules will require manufacturers to regularly summarise and assess device performance over time.

As well as the reforms on medical device surveillance, the UK government has this week announced plans to make it easier for individuals to volunteer to participate in clinical trials. Patients will be able to sign up to participate in trials via the National Institute for Health and Care Research (NIHR) Be Part of Research service on the NHS app, where they will be able to browse and select trials best suited to their interests and needs.

Eventually this will automatically match patients with studies based on their own health data and interests, sending them push notifications to their devices about relevant trials that they may wish to sign up to participate in.

NIHR is also launching a recruitment drive to find as many volunteers for trials as possible, including those from underrepresented groups including young people, Black people and people of South Asian heritage.

The MedTech landscape in the UK and EU is set for significant developments in 2025, with a focus on regulatory changes, sustainability, innovation and the potential roll-out across the NHS in England of a switch to value-based procurement.

UK Developments

1. Regulatory Changes: The UK is revising its medical devices legislation, with new regulations expected to be implemented in 2025. Further developments may include a framework to address advancements in medical device software and AI. NICE and the NHS are also developing a new MedTech pathway to streamline the approval and adoption process for innovative technologies.
2. AI Integration: The Medicines and Healthcare products Regulatory Agency [MHRA] is developing processes like the “AI Airlock” to streamline the approval of AI-based medical technologies.
3. Investment and Innovation: Reports suggest that tax incentives for clinical trials and changes to tax rules and pension regulation could attract more investment and skilled professionals to the UK HealthTech sector.
4. Circular Economy: The UK MedTech sector is increasingly adopting circular economy principles, focusing on sustainable product design, reusable devices, and reducing waste – driven by environmental concerns and potential cost savings. 2025 will see rapid progress down the roadmap for change.
5. Value-Based Procurement: The NHS in England is set to move towards value-based procurement [VBP], which focuses on the overall value and outcomes of medical technologies rather than just the initial purchase price, aiming to improve patient outcomes and reduce long-term healthcare costs. A new methodology for assessing VBP will be piloted by selected Integrated Care Systems and then rolled out across the NHS in England, becoming formal guidance by the end of 2025 and mandatory for use by end of 2026.
6. Late Stage Assessments by NICE: NICE has developed a late-stage assessment approach to evaluate technologies already in widespread use within the NHS. This process aims to ensure these technologies provide value for money and meet clinical effectiveness standards. Some parts of the MedTech sector subject to this process are complaining it is burdensome and unreasonable in its timetable, but NICE is determined to continue.
7. Drug Tariff Updates: The Department of Health and Social Care [DHSC] has proposed updates to Part IX of the Drug Tariff, which lists medical devices available for prescribing in primary care and sets the price to the NHS. The aim is to modernise the process and ensure the right products are available at the right price. Some product suppliers fear the changes could lead to restrictions on the freedom of clinicians to prescribe and patients to receive the most appropriate products, adversely impacting on patient experience and outcomes; and impacting on profitability and investment. The review could also lead to a new regulatory home for digital apps.

EU Developments

1. Regulatory Overhaul: The EU is holding a consultation on the current regulations governing medical devices and in vitro diagnostic devices. Subject to the outcome of that consultation updates to the regulations will likely follow.
2. Sustainability Focus: There is a growing emphasis on sustainability, with initiatives to develop reusable products and reduce waste in the healthcare industry.
3. Procurement: the EU is holding a consultation on the reform of procurement regulations across the whole of the EU, affording opportunities for the sector to lobby for a greater emphasis on value-based procurement.

The MedTech sector is dynamic, innovative and evolving, poised for further growth in the coming year, but there’s a real danger that regulatory and other policy changes risk hampering as well as helping the sector’s opportunity to fulfil its true potential. The sector must continue to engage with the EU institutions and the UK’s government and its agencies to maximise opportunities and minimise threats.

The Author used AI in preparing this article. Comments upon or questions about this article can be addressed to chris.whitehouse@whitehousecomms.com.

The expansion of the specialist services is anticipated to create a significant impact for the whole life sciences network over the next few years, through harnessing the expert and experienced personnel within regional Medilink organisations, to more effectively provide a national service offering to the UKs life science industry (medical devices, diagnostics, drug delivery systems, digital health companies), service and research institutions, NHS organisations, universities and combined authorities / development agencies. 

Kevin Kiely MBE, Group Chief Executive of Medilink UK said: “The life sciences sector has very specific needs and challenges, and it is now more important than ever to be able to provide a full specialist service offering spanning marketing and design, innovation / commercialisation, international market access and exhibitions and events. We have developed a strong track record of delivering such services within UK regions, so it seemed a logical development to move to national service delivery, providing a one stop shop for the life sciences sector.” 

The specialist services from Medilink UK include: 

DESIGN & MARKETING 

Expand your reach with marketing, PR and design solutions that align with your business goals and objectives. 

INNOVATION, COMMERCIALISATION & REGULATION 

Unlock your innovation capabilities, understand the regulatory environment, and ensure your products are compliant. 

INTERNATIONAL CONSULTANCY  

Medilink’s international trade and sector specialists work with companies around the UK to identify opportunities in new international markets, creating bespoke market entry strategies including regulatory regime and reimbursement routes, for companies of all sizes. 

EVENT & CONFERENCE MANAGEMENT  

Lose the stress of event management and have Medilink provide services from email campaigns through to fully managed events. 

Additionally, Medilink UK provide a number of activities to support the UK life sciences  

community, including International Exhibitions and Support, Medilink UK  

National Awards, and various Sponsorship Opportunities. 

Medilink UK is the largest representative body in the UK for life sciences, a unique network of not-for-profit regional organisations dedicated to improving healthcare across the country, with a strong track record in increasing the viability of manufacturers, service providers, designers, OEMs and suppliers of medical technology, pharmaceuticals, and biotechnology products. 
 
Additionally, their expert and experienced Medilink UK team provide a range of specialist services to support the life sciences community in the UK.