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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 Fen Mobility Centre as a new member. Fen Mobility Centre offers a comprehensive array of mobility solutions, alongside daily living aids, gadgets, and walking supports.
The BHTA recently caught up with Sara Cunnington, Director and Occupational Therapist at Fen Mobility Centre, to learn more about how Sara’s clinical background brings valuable expertise into the mobility sector and why being a BHTA member strengthens the company’s commitment to ethical trading, customer confidence, and keeping pace with industry developments.
Sara has worked as an occupational therapist (OT) for 17 years across Cambridgeshire and Fenland, primarily within community settings.
“Throughout my career, I have enjoyed every element of OT practice—from leading teams and supporting professional development to working directly with patients and helping them live more independently,” Sara said.
“My passion has always been about making a meaningful difference in people’s everyday lives, whether through tailored advice, practical solutions, or compassionate care.”
In 2025, Sara and her husband purchased Fen Mobility Centre, after long admiring the company’s impact within the community. This has given Sara the opportunity to bring her clinical expertise into the mobility sector, ensuring that customers benefit not only from high-quality products but also from the insight and support of someone who understands their needs from a healthcare perspective.
Sara continued: “I am proud to work alongside our excellent team to continue developing our service, expanding our product range, and ensuring that Fen Mobility Centre remains a trusted source of independence and support for our customers.”
Fen Mobility Centre offers a comprehensive array of mobility solutions—from mobility scooters and powerchairs to riser-recliner furniture, profiling beds, and home adaptations like stairlifts and ramps—alongside daily living aids, gadgets, and walking supports.
“Our services are as much about people as products,” Sara explained. “We provide test drives, home and showroom assessments, same-day collection or next-day delivery, setup services, equipment hire, insurance, servicing and repairs, all underpinned by a Zero Pressure Guarantee and excellent aftercare.
“With over three decades of experience, VAT-free pricing, and an onsite occupational therapist, our ethos centres on compassionate, professional support tailored to individual needs.”
Fen Mobility Centre’s recent strategic partnerships have expanded the retailer’s selection of travel-friendly mobility items, enhancing its ability to meet diverse customer requirements across Cambridgeshire and Fenland.
One of the key challenges for mobility businesses is keeping pace with the constant changes in policy, regulation, and best practice across the healthcare and mobility industry. This is a challenge faced not just by Fen Mobility Centre, but so many other firms in the sector.
To ensure that Fen Mobility Centre’s customers always receive safe, high-quality products and advice, the company needs to stay well informed and adaptable, Sara emphasised. Additionally, with the growth of online sales and evolving customer expectations, maintaining trust and demonstrating its commitment to ethical trading has never been more important.
Sara added: “By joining the BHTA, we gain access to expert guidance, updates on industry developments, and a network of trusted peers. This support will help us navigate regulatory changes more effectively, adopt best practices, and reinforce our promise to put customers first.
“Membership also gives us the opportunity to contribute to a collective voice that helps shape the future of our industry.”
Sara said she is especially keen to take part in BHTA webinars focused on policy and regulation, as keeping up to date in this area is essential for delivering safe, compliant, and trusted services to customers.
Fen Mobility Centre’s mission is to provide high-quality mobility solutions that genuinely improve the independence, safety, and wellbeing of its customers. The retailer states it is committed to upholding the highest standards of professionalism, transparency, and customer care.
Being a BHTA member means that Fen Mobility Centre can demonstrate its dedication to ethical trading, strengthen customer confidence through association with a trusted national body, and align with an organisation that shares its values.
Sara explained: “Membership will not only hold us accountable to the BHTA Code of Practice but also connect us with industry peers, best practices, and resources that will help us continue to grow responsibly while delivering exceptional service to the communities we serve.”
One major benefit of being a BHTA member is having the chance to network with likeminded industry peers for shared knowledge, learning, and expertise, especially at BHTA Section meetings, where relevant and important topics are discussed. This engagement opportunity is one that particularly appeals to Sara.
“I am really looking forward to engaging with the upcoming BHTA events, particularly as opportunities to connect and network with other businesses across the mobility and healthcare sector,” she commented.
“In addition, I see great value in attending BHTA events and Section meetings outside of my core area of expertise, as this will give me greater insight into parts of the healthcare landscape I don’t encounter regularly.
“By broadening my knowledge in this way, I can bring fresh perspectives back to Fen Mobility Centre and continue developing both our service and product offering.”
Fen Mobility Centre has exciting short-term and long-term plans for the future.
In the short term, the retailer’s focus is on enhancing and broadening its product range to meet an even wider variety of needs.
Sarah highlighted: “Alongside our core mobility and daily living equipment, we are placing greater emphasis on sensory products—items that support comfort, wellbeing, and independence not only through physical solutions but also through sensory engagement. This reflects our ongoing commitment to understanding the whole person and tailoring support that truly improves quality of life.”
Looking further ahead, Fen Mobility Centre hopes to expand beyond its single showroom, making its trusted service and ethos accessible to more communities. By opening additional locations, the retailer strives to provide the same compassionate, professional care, and high-quality product offering to a broader customer base, while maintaining the family-centred values that defines the company.
To find out more about how the BHTA can support your business and how to become a BHTA member, visit this page.
This consultation sought views on how professions are brought into, or removed from, statutory regulation of health and social care professionals across the UK. The aim of regulation is to protect the public from harm, ensuring that any regulatory approach is proportionate and effective.
The government proposed additional powers under the Health and Care Bill to enable greater flexibility, including the ability to remove professions from regulation, close regulators, delegate functions more freely, and extend regulation to new groups such as senior NHS leaders. The consultation explored the criteria that should be used to assess whether professions should be regulated in the future.
At the time, there were no plans to significantly change the current balance of regulated professions, which was considered appropriate for managing risk without placing unnecessary burdens on the workforce. The consultation formed part of a wider programme of regulatory reform aimed at simplifying the system, improving consistency, and strengthening public protection, including a review into whether the number of professional regulators could be reduced to improve efficiency.
Download the relevant documents:
Click HERE to download the consultation document.
Click HERE to download the BHTA response to this consultation.