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The Medicines and Healthcare products Regulatory Agency (MHRA), working with the Department of Health and Social Care, ran a call for evidence to inform its statutory review of the UK medical device regulatory framework.
The consultation received 123 responses from industry, trade associations, healthcare professionals, patient groups, and charities. To learn more about the consultation and see the BHTA’s full response, read this article.
As part of this work, MHRA held a workshop with trade associations, including the BHTA, to share early analysis from the responses and invite further input from stakeholders.
The figures below summarise the initial responses from stakeholders to the MHRA consultation.
When asked – How well do you think the current UK medical device regulatory framework protects public health? – most felt it offers protection to some degree, with 40 percent selecting ‘somewhat effectively’ and 35 percent ‘effectively’. A further 12 percent said ‘very effectively’. Five percent answered ‘ineffectively’, and seven percent were ‘not sure’.
To the question – On a scale where 1 = not at all effective and 10 = extremely effective, how effective are the regulations in practice? – scores clustered in the mid‑to‑high single digits, with the largest share around six to seven, and relatively few at the extremes. This indicates a broadly moderate view of day‑to‑day effectiveness.
See the slide below for views on unnecessary or excessive regulatory burdens and whether stakeholders have encountered any issues, blockers, or areas of ambiguity when using the regulations.
To the question – On a scale where 1 = not at all clear, well‑structured, or easy to navigate, and 10 = extremely clear, well‑structured, and easy to navigate, how would you rate the framework? – responses typically centred around six, with relatively few at the extremes.
When asked “Are there any overlapping, duplicative, or outdated provisions in the framework?”, 47 percent said ‘yes’, 42 percent ‘no’, and nine percent were ‘not sure’.
Views were cautious when asked: “Do the regulations provide the appropriate balance of flexibility to respond to new technologies or emerging public health issues, and robust regulatory oversight?” 42 percent disagreed and 11 percent strongly disagreed; 27 percent neither agreed nor disagreed; 17 percent agreed; and two percent strongly agreed.
Responses to the question – Do you think the current balance between what is set out in legislation and what is provided in supporting guidance appropriate? – received mixed responses. 19 percent answered ‘yes’. 28 percent felt too much sits in legislation, 21 percent felt too much sits in guidance, and 42 percent were unsure.
See the slide below for stakeholders’ views on streamlining medical device legislation.
On behalf of member companies, the BHTA welcomed MHRA’s engagement and added two pragmatic suggestions in the session:
According to discussions with MHRA, there will be further stakeholder workshops in October.
Findings from the survey and these workshops will inform the review, with a report expected early next year; all feedback will be anonymised in the final report.
The British Healthcare Trades Association (BHTA) has responded to a consultation seeking views from relevant stakeholders about the UK’s medicines and medical device regulatory framework.
Conducted by the Medicines and Healthcare products Regulatory Agency (MHRA), in collaboration with the Department of Health and Social Care (DHSC), the consultation focused on the legislation that govern the development, authorisation, supply, and oversight of medicines and medical devices in the UK. These include the Medical Devices Regulations 2002 and the Medical Devices (Fees) Regulations, which are relevant to BHTA members.
Ahead of the 19 September 2025 deadline, the BHTA invited members to share their views so that they could be included in the BHTA’s response to the consultation.
Read the BHTA’s full consultation response here.
“We strongly recommend extension of CE‑marked products in perpetuity, beyond the current 2028/2030 transition periods. The economic reality of the UK’s global market position means that patients, clinicians, and large commissioners (the NHS) will benefit most from continued acceptance of CE-marked products (which provides the most effective route to market for global/multi-national companies) AND a clear, robust, well-resourced domestic assurance route for UKCA-marked products (which provides the most effective route to market for UK-based SMEs who supply primarily (or only) the UK market).”
BHTA welcomes the intent of the medical device regulations but notes that recent uncertainty has affected companies and, ultimately, patients. Members have reported operational challenges stemming from shifting timelines for continued acceptance of CE-marked products, evolving fee structures, and a lack of clarity around the respective roles of MHRA and UK Approved Bodies.
“Businesses need predictability, appropriate advance notice, and clear regulatory pathways in order to invest confidently.”
BHTA’s view is that the regulations are broadly fit for purpose; however, MHRA resourcing and service performance must keep pace with regulatory demands. Increases in fees should be matched by measurable improvements in timeliness and quality of service delivered by the MHRA.
“Timely production of indicative fees, well before 01‑Apr‑26, will be essential… [and] quarterly or monthly payment plans for UKRPs… will be essential.”
BHTA recognises MHRA’s work towards an algorithm-based post-market surveillance cost-recovery model using GMDN level 2 categories. To help businesses plan, the association urges early publication of indicative fees well ahead of the model’s commencement on 1 April 2026.
Flexible payment options, such as quarterly or monthly plans for UK Responsible Persons acting for multiple manufacturers, would ease the transition. Any changes should be accompanied by transparent, public performance metrics and consistent delivery.
Greater clarity is required on the division of responsibilities between MHRA and UK Approved Bodies, particularly as international recognition (IR) routes are developed. BHTA supports IR in principle, but asks for timely, practical guidance on how any additional information will be collected, assessed, and used by the regulator and Approved Bodies, to avoid duplication and delay.
BHTA also advocates for closer alignment with trusted international regulators to reduce duplicative evidence requirements and restore the UK’s attractiveness as a launch market. In this context, the association supports making CE mark recognition permanent for medical devices in the UK without a time limit to stabilise supply chains, avoid unnecessary duplication, and maintain effective access.
“By aligning regulatory procedures and decision-making with international standards, the UK can offer businesses greater predictability, minimize duplication of evidence requirements, and accelerate product entry into the market. We firmly support the continued acceptance of CE-marked medical devices in the UK without a time limit.”
“The existence of separate legislation for medical devices in Great Britain and Northern Ireland creates an unnecessary burden. Differing requirements and duplicated regulatory submissions add complexity, raise compliance costs, and discourage innovation. This regulatory split can delay the availability of new devices in one or both regions, without delivering any clear improvements in safety or quality.”
In response to the MHRA’s question about unnecessary and excessive regulatory burdens, the BHTA also calls for improved access to expert, ‘actual-human’ advice alongside digital portals, so registrants can resolve complex issues more efficiently without ad-hoc escalation.
BHTA further supports DHSC/MHRA work to enable reuse of appropriate single-use Class I medical devices, where safe, as part of a pragmatic approach to sustainability, cost control, and patient access.
“Keeping regulatory detail to a minimum while expanding on it within guidance allows MHRA to respond more rapidly and effectively.”
To keep pace with technology and public health needs, BHTA favours placing more technical detail in guidance rather than in legislation. Guidance can be updated more rapidly, allowing regulators and industry to respond quickly while maintaining safety. The association also encourages early and continuous engagement with stakeholders in the development of guidance, reflecting lessons from the pandemic period when temporary flexibilities were introduced without major issues.
Our response: New regulations made under the Medicines and Medical Devices Act (MMDA)
“The shift to a cost‑recovery model occurred while MHRA was dealing with significant backlogs… any fee increases should be accompanied by more consistent and prompt delivery of MHRA services.”
The BHTA has engaged with several statutory instruments made under the Medicines and Medical Devices Act, including changes to fees and extensions for CE-compliant devices in Great Britain. Operation to date is assessed as ‘somewhat effective’. However, the shift to cost recovery coincided with backlogs, underlining the need for clear communication, adequate resourcing, and stronger performance management. Any fee increases should be accompanied by timely services and enhanced staff capability.
“We strongly support MHRA’s recent renewed openness to engagement with industry, and to proactive collaboration.”
The BHTA emphasises that MHRA having ongoing dialogue with industry and patients will help ensure that regulation and guidance are workable, support innovation, and maintain safe access to medical technologies.
The British Healthcare Trades Association (BHTA) has welcomed ProSys International as a new member. ProSys International designs, develops, and manufactures a range of clinical supplies and medical devices for acute and secondary care environments.
The BHTA recently caught up with Gill Sims, Clinical & Commercial Director at ProSys International, to discover more about the firm, the value of being a BHTA member, and difficulties keeping up with the latest regulations.
Gill enjoyed a successful career in medical device sales for over 30 years. She has previously worked in the stoma, urology, wound, and obstetrics and gynaecology markets.
Gill recently joined ProSys International to support the firm’s vision and business development strategy in expanding its bowel management, pressure area care, and infection control portfolio in both primary and secondary care environments.
“As a registered nurse I am passionate in supporting healthcare professionals with best practice solutions to support and overcome the challenges faced in today’s clinical and home care settings,” Gill enthused. “Providing products and educational services to enable care of the highest standard is our goal and we are building a respected team to spread our reach and support at grass roots.”
Gill says that contributing to the development of exciting new products in the pipeline in a dynamic environment is incredibly rewarding. ProSys International’s overall goal is to deliver high-quality and cost-effective solutions, which involves multidisciplinary professionals supporting the firm’s projects from the outset.
The company anticipates launching its latest development in early 2025. This will mark the start of a programme that sees the true development of the ProSys International brand over the next three years.
Prosys International is a micro SME founded in the late 1990s by Graham Steer. As a mechanical and bioengineer, Graham grew the business with a focus on the design, development, and manufacturing of medical devices.
The company developed a range of products to assist in the management of highly infectious bodily fluids based upon super absorbent systems, and this subsequently led to the development of the Secco Faecal Management system. The Secco Faecal Management System Secco Protect™ is an easy-to-use system that reduces skin breakdown and pressure ulcer development, while preventing cross contamination. With its unique super absorbency technology, it contains spillages and odours as well as maintains patient dignity.
“Most recently a range of pressure relieving devices were added to the product portfolio, and this addition will be a focus for the business as we move in a new strategic direction,” Gill adds.
The ProSys International range of products are sold via a range of distribution channels including the NHS Supply Chain.
Gill explains that, for a small team, it is difficult to keep up to date with the latest regulations, as resources are stretched.
She says: “For any size organisation the trials and tribulations of endeavouring to comply with both regulatory and voluntary requirements in the 21st Century is like ‘pushing water uphill’, but with the added issue of reduced resources in a company the size of ProSys our small team can be stretched, regulatory compliance is without a doubt our biggest challenge ahead.
“Barry Holland, Regulatory Affairs Manager for the company, explains that the two main adverse events in recent history that caused most disruption within the compliance field have been the PIP Breast Implant Scandal of 2010 and Brexit in 2020.
“Regulations have been strengthened (and lengthened), Notified Bodies are now relying on State-of-the-Art obligations with typical guidelines such as MEDDEVs (although most don’t have any legal status), and now, if we’re lucky enough to sell our medical devices into Europe, our costs to comply with both the EU Medical Devices Regulations 2017/745 and the UK Medical Devices Regulations 2002 have doubled.
“Politicians continually say that “red tape” will be reduced, but unfortunately this never happens! Government Quangos continue to publish commitments that micro businesses and SMEs be given a “light touch” approach, but again we are yet to see this happen.
“The challenges for medical device compliance have never been tougher.”
Gill says that joining the BHTA as a member will help give ProSys International a collective voice. The BHTA can also provide valuable support and guidance in overcoming some of these challenges.
There are many benefits to becoming BHTA member. For Gill, the most value comes from regulatory support, networking opportunities, educational sessions, being part of a collective voice, and aligning with the BHTA Code of Practice.
Gill comments: “Joining the BHTA was a no-brainer for me, having worked for several member companies in the past, I have enjoyed the networking opportunities, educational events, and the collaborative approach to our industry challenges.
“The BHTA Code of Practice aligns so well with the ProSys mission and values and reflects a philosophy of care and support, which is very much at the forefront of all our activities.
“I am so looking forward to meeting with the Section members in the coming months and engaging in discussions that enhance quality of life for our customers whilst developing and growing our respective businesses.”
To find out more about how the BHTA can support your business and how to become a BHTA member, visit this page.
The British Healthcare Trades Association (BHTA) has welcomed LendoCare as a new member. LendoCare’s goal is to simplify access to at-home medical equipment through rental models.
The BHTA recently caught up with Solomia Boretska, CEO/Co-founder of LendoCare, to find out more about the firm, its plans for the future, and how the BHTA can support with key issues.
Solomia is a neuroscientist by background, as she explained: “I volunteered with the MND Association during my studies and saw firsthand the difficulty of accessing equipment across the UK.”
That is when LendoCare was born.
“I started the business with my brother and co-founder to tackle the lack of digitalisation in the equipment hire process for customers,” Solomia continued.
LendoCare is building the digital equipment hire service for the UK, offering customers easy availability and a booking platform. Its mission is to tackle the postcode lottery of care by providing affordable healthcare equipment services at a national scale. Looking ahead, LendoCare plans to expand into the electric wheelchair and scooter sector.
LendoCare decided to become a BHTA member for several reasons.
As LendoCare expands, it is seeking support with medical device registration regulations and supply chain support. These are two areas where the BHTA can offer expert guidance.
LendoCare also wants to learn from other BHTA members in the space and receive up-to-date and relevant regulatory information.
Solomia added: “I’m keen to attend some in person events as well as Section meetings.”
To find out more about how the BHTA can support your business and how to become a BHTA member, visit this page.
Recently, leading medtech suppliers had the chance to attend the British Healthcare Trade Association (BHTA) conference, ‘UK Health and Social Care Landscape: How will UK policy decisions impact patient experience?’.
Both BHTA members and non-members were invited to the spring conference to discover how current policy decisions are shaping the future of health and social care, impacting UK patients, and what this change means for businesses.
Sponsored by Verlingue, the sell-out conference took place on 11 May 2023 at the Manor Hotel in Meriden, Solihull.
The conference saw an impressive roster of senior government and sector leaders present engaging sessions throughout the day to suppliers about future policy directions, new UK Government priorities, and how collaboration and innovation will ultimately improve the patient experience.
Attendees gained invaluable insights into the changing health and social care landscape, asked questions to the high-profile speakers, and networked with key stakeholders and peers.
Below are the highlights from the afternoon sessions from David Lawson, Director of MedTech; Purvi Patel, BSI Regulatory Lead for Medical Devices & IVDs; and William Lee, BHTA Head of Policy & Compliance.
Topics in these sessions included tackling procurement inconsistencies, keeping up government engagement with the medtech industry, and the complex UK regulatory landscape regarding medical devices.
The first set of morning presentations from David Stockdale, BHTA CEO; Steven Ferguson, Head of Market Access at IQVIA; and Paul Gaffney, Director of Tendo Consulting, can be found here.
These sessions explored how the BHTA is successfully lobbying on behalf of its members, how tackling NHS waiting lists with innovative technology is a priority, and how the changing political landscape is impacting healthcare policy.
The second set of morning talks from Simon Williams, Local Government Association Director of Social Care Improvement, and Alan Wain, COO at EPSCOT can be read here.
These presentations looked at social care reform, how better use of technology could improve the lives of millions of social care users, and how social value in public procurement impacts suppliers.
David Lawson, Director of MedTech, discussed the UK MedTech Strategy and its implementation plan.
He reinforced a key theme that was discussed throughout the conference: that innovation adoption within the healthcare sector is an immediate priority. There is lots of opportunity in medtech and a sense of urgency in the sector to tackle NHS issues.
“When I’ve spoken to people in the industry, NHS England, NHS Supply Chain, MHRA, NICE, and life science, my sense is there’s a general consensus about what the challenges are in medtech,” he commented. “There’s also a consensus about potential solutions. The challenge is trying to get things done.”
David reflected on what he presented at the BHTA Integration and Sustainability Conference 2022 in September last year. One of the things he discussed at that event was about a commitment to industry engagement from the Department of Health and Social Care (DHSC).
“I feel that has been quite positive for me to get different views, meeting with different suppliers, and meeting with the BHTA numerous times,” he said. “I’m keen that I keep that engagement up.”
The UK Government’s priorities are technology as an enabler and the importance of the life science industry. David highlighted that the Secretary of State sees medtech as a key priority and a solution to the NHS’ challenges, especially in regard to innovation adoption. The government also sees medtech and life sciences as an opportunity for growth in the economy.
“If we look at the Autumn Statement from last year, the Chancellor announced additional funding for MHRA to support them under their regulatory reform work and provide immediate access in terms of innovation,” he explained. “It’s unusual for a chancellor to talk about medtech in an Autumn Statement, but it reflects the fact that politically medtech has got quite a lot of momentum behind it.”
David noted challenges have been raised by industry around procurement inconsistencies, such as social value, inflation, and net zero. This is creating frustration within industry, as it means suppliers have to keep taking different approaches to tenders.
A key catalyst for improvement in this area, he said, is the NHS Central Commercial Function (CCF). He pointed towards Jacqui Rock, who is the chief commercial officer for NHS England and the CCF.
“There is a lot of leadership now in the system at that level that recognises these challenges and wants to engage and sort them out,” he continued. “Jacqui’s been having forums around SMEs, social value, and other areas. Jacqui is in an ideal position to drive improvement across the procurement landscape.”
David added that there is an issue with adopting innovation at scale in the NHS.
“This is an area of genuine frustration when you’re shown around hospitals where there’s great medtech solutions and you ask when they’re being deployed across the country and they don’t have an answer,” he explained. “We’re passionate about solving the adoption problem.”
He also recognised that the innovation pipeline for medtech is not joined up and there is a lack of clarity about what the process is. This is an area of particular focus for getting greater clarity of the process in terms of innovation adoption.
“For new innovations coming through,” he added, “how do we assess them and how do we make informed decisions? Once we’ve made the right impact, how do we get through levels of reimbursement and adoption?
“For solutions already on the market, how do we make important decisions about assessment and clarify the adoption of the most effective products in the market?”
David also delved into the MedTech Strategy, emphasising that it is centred around the vision of “right product, right price, right place”.
“The right product is about what is the most effective product to use?” He commented. “The challenge with medtech is that there are half a million medical devices being used in the UK. How do we measure what is the most effective products to use?
“Right price is about value-based healthcare. How do we understand the impact of products on patient outcomes? How do we get consistency across this area?
“Right place is partly about resilience but also about equity to access as well.”
The delivery of the strategy is led by different agencies: NICE, DHSC, NHSE, NHS Supply Chain, and MHRA. David said a key goal is about aligning this collaborative work across the agencies.
He explained: “For example, product evaluations are led by NICE. What we want to do is make sure there’s a connection between what NICE do with NHS England from a commissioning perspective but also if there are class-based evaluations impacting on products that NHS Supply Chain manage that the outcomes of those assessments feed into the category strategy and relations that the supply chain has. Otherwise, what’s the point in doing it? It’s about having a joined-up approach to tenders.”
David also discussed the strategy’s part IX tariff and its three areas of focus: the ability to review listed products, the assessment process to list products, and prescribing practice (second phase). A targeted consultation is due to come out at the end of July 2023 on part IX of the MedTech Strategy.
Purvi Patel, BSI Regulatory Lead for Medical Devices & IVDs, spoke about the UK regulatory landscape regarding medical devices.
She said that Brexit has had a big impact on the UK medtech regulatory landscape. Placing a medical device on the GB market with the UKCA mark is now mandatory from 1 July 2025; anything that is CE-marked and placed on the UK market is valid until 30 June 2025, after that point, medical devices need a UKCA mark.
“That’s through registration with the MHRA, having a conformity assessment done through an approved body, and then you’re able to place your device on the GB market,” commented Purvi.
“If we look at Northern Ireland, the route BSI offers for placing medical devices on this market, as an approved body, is the CE mark. There is something called the CE+UKNI mark. That’s not something that BSI offers because the UKNI mark isn’t recognised by the EU.”
She continued: “There was a change in March 2023. The European Journal published a legislation – 2023/607 – and this is dealing with those devices that have been certified under the directives having an extension granted with the timelines of 31 December 2027 for Class III devices or IIb implantables that are not well established technology, which are allowed to be, under the directives, on the market until 30 June 2028.
“So we have the EU timelines with what’s valid under the directives up until 2027/2028, but then we also have now the UK legislation saying that we have until the 30 June 2028 for medical devices complying with the new UK legislation. Then 30 June 2030 by which we need to have IVDs complying with the new UK legislation.”
This has caused complexity for medical device manufacturers around: what they need to do with their directive certificates, because they’ve got extended validity now based on certain conditions; what to do with devices that are certified under current UK legislation; and thinking about future UK legislation and timelines.
“To place devices on the UK market, you need to have registration with the MHRA, a declaration of conformity, UK designated standards, an appointed UK responsible person, and labels showing a UKCA mark or CE mark,” she added. “Those are the extra UK requirements.”
Purvi helpfully explained what conformity assessment looks like for UKCA at BSI and detailed various scenarios:
“The other two options are if you combine the applications,” Purvi continued. “We do see applications where manufacturers have got their MDR assessment in and they’re formally applying for a UKCA certification at the same. We would follow the MDR certification processes look for the UK-specific requirements as well – we’d assess that at the same time – so we’d do things like combine the QMS audits and combine microbiology audits.
“The final scenario is if you’ve got a combined application with UKCA with IVDs – so if you’ve got a certificate under the IVDR and you’re looking for UKCA certification, which we’d leverage off the IVDD – we’d combine the QMS audits and the microbiology audits, but we’d have to do standalone technical documentation reviews because of the differences in classification with the IVDs between the directives and regulations.”
Purvi explained that there are three lists of designated standards in the UK: medical devices, IVDs, and active implantable medical devices. These standards can be found on the UK Government website.
She then discussed UKCA placement on medical devices.
In Great Britain, UKCA placement needs to be on the device or on the sterile pack (where appropriate), any sales packaging for the device, and instructions for the device. For products being placed in Northern Ireland and the EU as well as in Great Britain, both the CE mark and UKCA mark will need to be placed on the medical device.
Importantly, she reminded firms that they need to approach BSI as early as possible when getting devices UKCA marked because it is very busy and capacity is not limitless.
The last presentation of the day was delivered by William Lee, BHTA Head of Policy & Compliance.
He noted that while the MHRA aims for new medical device regulations to be in place for 1 July 2025 in its guidance, this date does not appear in statutory instruments (SIs).
Bill also discussed medical device transitional arrangements.
“The transitional arrangements have changed slightly,” said Bill. “CE-marked devices under the EU MDR can, under certain conditions, stay on the GB market until the new regulations take effect, i.e., 1 July 2030. It seems clear that MHRA intends to make a further change that would mean that you needed to apply the phrase ‘whichever is sooner’ under the EU MDR.
“Similarly, medical devices CE-marked under the EU MDD can stay on the GB market for three years, under certain conditions, after the regulations take effect, which takes us up to 2028.
“Our understanding was that the previous transitional arrangements applied to all classes of medical devices.
“I think the biggest change and the most relevant change for BHTA members is that for Class I products that do not require third-party conformity assessments – so standard Class I products that aren’t sterile, don’t have a medical function, and that aren’t reusable surgical instruments – the new transitional arrangements will not apply. These Class I products will need to comply with UK regulations and display the UKCA mark from the new date of inception.”
Bill explained that the SI has been laid before the House of Commons and the House of Lords in a draft affirmative. If the medical device SI is approved, it passes into law on 30 June 2023.
BHTA is currently seeking clarity from MHRA regarding the 1 July 2025 inception date, Class I device transitional arrangements, labelling requirements, and securing MHRA guidance webinars for members.
The association will issue a guide to BHTA members on UK medical device regulation and laws in the coming weeks.