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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.