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Click HERE to download the BHTA response to the MHRA pre-market medical devices regulation stakeholder impact survey.
MHRA has published its plans for future regulation of medical devices in the UK, draft Medical Devices (Amendment) Regulations 2026 (The Regulations). In line with the UK’s post-Brexit obligations under the World Trade Organization (WTO), MHRA notified the draft Regulations to the WTO on 8 May 2026; WTO members now have until 7 July 2026 to comment.
These Regulations represent the most significant reform of GB’s medical device framework in recent years, modernising pre-market requirements while improving access to devices already approved by other leading international jurisdictions. The Regulations will take effect in two phases:
MHRA Survey
MHRA requested that all interested stakeholders review the guidance questions for the Regulations and complete a survey on the impact of the Regulations by 19 June 2026. BHTA also completed the survey, but it was crucial that MHRA heard directly from industry, particularly manufacturers. The survey and supporting documents were available at:
Primary changes in the draft medical devices (amendment) regulations 2026
In summary, the main changes are:
In detail, the main changes are:
WTO Notification and relevant documents
The WTO notification is viewable at: G/TBT/N/GBR/120 The Medical Devices (Amendment) Regulations 2026.
The draft Regulations are viewable at draft Medical Devices (Amendment) Regulations 2026 (The Regulations), and the underlying documents referred to the draft Regulations are viewable at:
Upcoming BHTA / AXREM webinar with MHRA
Following the survey, BHTA and AXREM hosted a joint webinar featuring speakers from the MHRA on Thursday 9 July 2026. The session provided an overview of recent regulatory developments and key updates from the MHRA relevant to industry stakeholders. Members who would like a copy of the presentation slides can request them by emailing katie.edgington@bhta.com
This consultation sought views on proposed changes to the legal framework governing powered mobility devices, including mobility scooters and powered wheelchairs. Led by the Department for Transport, the review considered whether existing legislation remains appropriate in light of technological developments and increased use of these devices.
The consultation explored issues such as vehicle classification, safety requirements, speed limits, and use in public spaces, with the aim of ensuring that regulation remains proportionate while supporting safe and accessible mobility. It also considered how changes could impact users, manufacturers and suppliers.
The BHTA encouraged members to review the proposals and consider any potential implications for product design, compliance and market access.
Download the relevant documents:
Click HERE to download the consultation document.
Click HERE to download the BHTA response to this consultation.
This consultation outlined proposed changes to the classification of medical devices in the UK as part of wider regulatory reforms. Led by the MHRA, the proposals aimed to align the UK’s approach more closely with international frameworks and introduce a more risk-based system.
The consultation described how devices are currently classified and proposed updates to ensure the regulatory framework remains appropriate as technologies evolve. The changes aimed to better reflect the level of risk posed to patients and the public.
The BHTA encouraged members to review the proposals and consider any potential implications for product classification, regulatory requirements and market access.
Download the relevant documents:
Click HERE to download the consultation document.
Click HERE to download the BHTA response to this consultation.
The Department of Health and Social Care’s consultation on Fair Pay Agreements in Adult Social Care sought views on the proposed Adult Social Care Negotiating Body (ASCNB), which would bring together employer and worker representatives to negotiate pay, terms and conditions across the adult social care sector.
The BHTA actively encouraged members to engage with the consultation, ensuring the views of healthcare suppliers and community equipment service providers were represented. Member feedback informed the Association’s response, which highlighted the need for greater clarity on which roles would fall within the scope of the proposed framework, particularly within community equipment services, as well as the importance of practical guidance and support to help employers implement any future changes.
Download the relevant documents:
Click HERE to download the consultation document.
Click HERE to download the BHTA response to this consultation.
This consultation sought views on proposed regulations and guidance to strengthen action against modern slavery in NHS procurement. Building on the Modern Slavery Act 2015 and the Health and Care Act 2022, the proposals introduced new legal duties for public bodies procuring goods and services for the NHS to assess and address risks of modern slavery in their supply chains.
For BHTA members, the proposals highlighted increased expectations around supply chain due diligence, transparency and compliance, particularly for suppliers working with NHS organisations. The measures aimed to ensure that NHS procurement activities are free from unethical labour practices, while aligning with wider government policy on tackling modern slavery.
The consultation also outlined how these duties would be supported by national guidance and applied across public sector procurement in England. The BHTA encouraged members to consider the potential operational and reporting implications for their organisations.
Download the relevant documents:
Click HERE to download the consultation document.
Click HERE to download the BHTA response to this consultation.
The MHRA’s consultation on Medical Devices Regulations: Routes to Market and In Vitro Diagnostic Devices sought views on a range of proposed reforms to the UK medical devices regulatory framework. Key proposals included the introduction of an international reliance route to allow certain devices approved in comparable overseas jurisdictions to access the Great Britain market more quickly, the removal of UKCA marking requirements, new routes to market for in vitro diagnostic (IVD) devices, and measures to maintain elements of assimilated EU law during the transition to a future regulatory regime.
The BHTA encouraged members to engage with the consultation and share feedback on the practical implications of the proposals. Drawing on member views, the Association broadly supported measures aimed at improving market access and reducing unnecessary regulatory burden, including the introduction of international reliance routes and the removal of UKCA marking requirements. The BHTA’s response also highlighted the need for greater clarity around UK-specific requirements, device classification processes, approved body capacity and costs, and the practical implementation of the proposed framework to ensure that patient access to medical technologies is maintained while supporting innovation and regulatory.
Download the relevant documents:
Click HERE to download the consultation document.
Click HERE to download the BHTA response to this consultation.
The MHRA’s 2024 consultation on statutory fees sought views on proposals to increase regulatory fees and introduce new cost-recovery measures for medical devices. The proposals included increases to existing fees, the introduction of annual registration fees linked to GMDN codes, and a new paid regulatory advice service intended to support medical device manufacturers and suppliers.
The BHTA encouraged members across the medical technology sector to engage with the consultation and share evidence on the likely impact of the proposed changes. Drawing on member feedback and detailed analysis, the Association’s response highlighted concerns around rising regulatory costs, the potential effect on innovation, investment and market access, and the cumulative financial burden facing businesses already operating in a challenging economic environment. The BHTA also emphasised the importance of ensuring that the UK remains an attractive and competitive market for medical technologies while maintaining effective regulatory oversight.
Download the relevant documents:
Click HERE to download the consultation document.
Click HERE to download the BHTA response to this consultation.
This consultation sought views on proposals to develop a more integrated, rules-based and predictable pathway for the evaluation, funding and commissioning of medical technologies in the NHS. The proposed pathway aimed to cover the full lifecycle of medtech, from early innovation through to routine adoption, with a focus on improving patient outcomes and delivering better value for the NHS.
For BHTA members, the proposals signalled a move towards clearer and more structured market access processes, with a stronger role for NICE in linking clinical and cost-effectiveness assessments to funding decisions. The approach aimed to provide greater certainty for innovators and suppliers, while supporting faster and more consistent adoption of effective technologies.
The consultation formed part of the wider Medtech Strategy and broader NHS reforms, with an emphasis on reducing complexity, supporting innovation and enabling more value-driven decision-making. The BHTA encouraged members to consider the potential implications for evidence generation, market access and adoption.
Download the relevant documents:
Click HERE to download the consultation document.
Click HERE to download the BHTA response to this consultation.
This consultation sought views on proposed changes to the NHS Standard Contract for 2024/25. The Contract is published by NHS England and used by commissioners to procure most healthcare services in England, excluding primary care. It includes both a full-length version and a shorter-form version for less complex and lower-value services.
The consultation outlined material updates to both versions of the Contract and invited feedback from stakeholders, along with wider suggestions for improvement. Responses were submitted via the NHS England Consultation Hub, supported by a stakeholder response collation document to gather input across organisations.
The BHTA encouraged members to review the proposed changes and consider any potential implications for their organisations.
Download the relevant documents:
Click HERE to download the consultation document.
Click HERE to download the BHTA response to this consultation.
This consultation sought views on the potential introduction of new secondary legislation requiring manufacturers and suppliers of medicines, medical devices and borderline products to report payments and other benefits provided to healthcare professionals and organisations.
For BHTA members, the proposals signalled a significant shift towards increased transparency obligations across the health sector, with potential implications for reporting requirements, administrative burden and commercial relationships. The measures aimed to address concerns around real and perceived conflicts of interest, as highlighted in the IMMDS review, and to strengthen patient trust and confidence in clinical decision-making.
The consultation also considered how transparency could be improved while minimising impact on industry. The BHTA encouraged members to review the proposals and consider the potential operational and compliance implications for their organisations.
Download the relevant documents:
Click HERE to download the consultation document.
Click HERE to download the BHTA response to this consultation.
This consultation invited feedback on proposed changes to MHRA statutory fees, including a 10% increase, targeted adjustments to address under-recovering fees, and the introduction of new charges for certain services. These proposals were intended to ensure the MHRA can sustainably deliver high-quality, efficient regulatory services. BHTA encouraged members to review the proposals and consider the potential impact on the medical technology sector and associated businesses.
Download the relevant documents:
Click HERE to download the consultation documents.
Click HERE to download the BHTA response to this consultation.
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.
The Department of Health and Social Care’s supplementary consultation on the Provider Selection Regime (PSR) sought views on proposals to replace existing healthcare procurement rules with a more flexible framework focused on collaboration, integration and patient outcomes. The proposed regime would govern how NHS bodies, integrated care boards, local authorities and NHS trusts arrange healthcare services, reducing reliance on competitive tendering while maintaining transparency, proportionality and accountability in provider selection decisions.
In its response, the BHTA broadly supported the objectives of the Provider Selection Regime, particularly efforts to improve clarity, reduce unnecessary procurement burdens and support integrated care delivery. The Association highlighted the importance of clear definitions and reference points, including the use of Common Procurement Vocabulary (CPV) codes to define service scope, and advocated for the inclusion of services such as wheelchair, community equipment and continence provision. The response also raised concerns about proposed thresholds for contract changes potentially disadvantaging SMEs and innovative providers, while emphasising the need for fair market access, transparency and continued opportunities for specialist healthcare suppliers.
Download the relevant documentation:
Click HERE to download the consultation – document 1
Click HERE to download the consultation – document 2
Click HERE to download the consultation – document 3
Click HERE to download the BHTA response to this consultation.
This consultation sought views on proposed changes to the NHS Standard Contract for 2022/23, which was used by NHS commissioners to procure most healthcare services in England, excluding primary care. It covered both the full-length contract and a shorter-form version for less complex services.
The updates were set in the context of the Health and Care Act reforms, which introduced Integrated Care Boards (ICBs) as the new commissioners responsible for arranging services and contracting with providers. The NHS Standard Contract continued to provide a nationally mandated framework to ensure consistent standards, reduce administrative burden, and support fair competition between NHS and independent providers.
The consultation invited feedback on the proposed changes and broader improvements, with the Contract expected to evolve over time to reduce bureaucracy and support greater integration across local health systems.
Download the relevant documents:
Click HERE to download the consultation document.
Click HERE to download the BHTA response to this consultation.
This MHRA consultation sought views on a comprehensive overhaul of the UK medical devices regulatory framework following the UK’s departure from the EU. The proposals aimed to strengthen patient safety, increase transparency, support innovation, and align the UK with international best practice. Key areas included changes to device classification, software and AI regulation, in vitro diagnostics (IVDs), post-market surveillance, clinical investigations, unique device identification (UDI), economic operator responsibilities, and new routes to market for innovative technologies. The consultation formed part of the UK’s plans to establish a modern, proportionate regulatory system that supports both patient protection and the growth of the life sciences sector.
The BHTA encouraged members from across the medical technology sector to review the proposals and submit responses, helping to ensure that the views and practical experiences of manufacturers, suppliers and service providers were reflected in the development of the future UK regulatory framework.
Download the relevant documents:
Click HERE to download the consultation document.
Due to the document’s format, the BHTA response is available on request. Please email william.lee@bhta.com or katie.edgington@bhta.com to receive a copy.