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DfT – Reviewing the Law for Powered Mobility Devices

DfT – Reviewing the Law for Powered Mobility Devices

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.

MHRA – Indefinite Recognition of CE Marked Devices

MHRA – Indefinite Recognition of CE Marked Devices

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.

DHSC – Tackling Modern Slavery in NHS Procurement

DHSC – Tackling Modern Slavery in NHS Procurement

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.

NHS – Building an Integrated and Rules-Based Medtech Pathway Consultation

NHS – Building an Integrated and Rules-Based Medtech Pathway 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.

NHS Standard Contract Consultation 2024/25

NHS Standard Contract Consultation 2024/25

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.

DHSC – Disclosure of Industry Payments to the Healthcare Sector Consultation

DHSC – Disclosure of Industry Payments to the Healthcare Sector 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.

MHRA – Statutory Fees Consultation

MHRA – Statutory Fees 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.

DHSC Consultation – Healthcare Regulation: Deciding When Statutory Regulation is Appropriate

DHSC Consultation – Healthcare Regulation: Deciding When Statutory Regulation is Appropriate

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.

NHS Standard Contract Consultation 2022/23

NHS Standard Contract Consultation 2022/23

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.