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 Medicines and Healthcare products Regulatory Agency (MHRA) has launched a targeted consultation on proposals for the indefinite recognition of CE-marked medical devices in Great Britain (GB). The consultation seeks views on measures intended to protect patient access and ensure the continued supply of safe and effective medical technologies.

For BHTA medical device manufacturer members, this consultation is significant. The outcome will shape the long-term regulatory framework for CE-marked devices in GB, with implications for market access, certification planning and regulatory strategy. This is a key opportunity for members to help inform the final approach.

What is being proposed?

The consultation seeks views on three key proposals:

• Extending current transitional arrangements for devices certified under the EU Medical Device Directive (MDD), aligning GB timelines with the EU’s transition to the EU Medical Device Regulation (EU MDR), to minimise the risk of supply disruption.
• Indefinite recognition of EU MDR and EU IVDR-compliant devices, to reduce the risk of interruption to the supply of medical devices for patients in GB.
• Introducing an international reliance route for a small proportion of CE-marked devices that would fall into a higher risk class under GB rules, to ensure appropriate oversight while maintaining access.

The MHRA has stated that indefinite recognition of CE-marked devices would help ensure continued patient access to essential medical technologies, while being delivered alongside a domestic route to market focused on supporting innovation.

Lawrence Tallon, Chief Executive at the MHRA said: “The number one request that the med tech industry made of us was to provide long term certainty over CE recognition. It is in the best of interests of British patients to ensure continued access to the latest medical devices approved in Europe. It is also in the best interests of the med tech sector to reduce friction and costs of doing business. We have listened carefully and acted on this clear and consistent feedback, which is why we are now pleased to consult on these proposals for indefinite recognition of CE marked medical devices.”

The proposals extend arrangements first introduced in 2023 to recognise CE-marked devices on the GB market and form part of the MHRA’s wider programme of medical device regulatory reform. They also align with wider government policy for other manufactured goods sectors where continued recognition of CE-marked goods has been agreed. Alongside these measures, the MHRA has confirmed that it will continue to strengthen post-market surveillance and improve information sharing with EU partners.

For members supplying CE-marked devices in GB, the consultation represents an important opportunity to provide practical feedback on how the proposed approach would operate in practice and to highlight any potential unintended consequences.

Respond to the MHRA consultation.

The consultation closes on 10 April 2026.

The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a call for evidence on how it should prioritise the designation of standards for medical devices in Great Britain, to inform future work under the Medical Devices Regulations (MDR) 2002.

Scope of the call

The exercise focuses on device standards used for medical devices placed on the Great Britain market. It invites views on the current list of designated standards and asks stakeholders to identify further standards that could be considered for future designation.

The MHRA states: “Designated standards are specific standards that have been officially recognised by regulatory authorities in the UK as providing a presumption of conformity with the essential requirements of relevant regulations.

“When a device complies with a designated standard, the device meets relevant essential requirements the standard addresses.”

What the consultation asks

The questionnaire requests factual information on how organisations use device standards in practice, and invites detailed suggestions about the content of the designated list.

Examples include:

• Whether already-designated standards are used to support compliance with MDR 2002, and which of those are used most frequently or are considered most important.
• Whether additional, non-designated standards should be added to the designated list, with fields to specify the standard and provide supporting detail.
• Whether any standards should be removed from the current designated list.
• Whether standards should be replaced with alternatives or updated where newer editions exist.

The survey also asks respondents to rate the practical value of designated standards for market access; for example, whether using designated standards provides time savings in submission and approval processes, and whether mappings to essential requirements are useful.

Context within ongoing reforms

This activity forms part of the MHRA’s wider programme to develop the future regulatory framework for medical devices in Great Britain, aiming to prioritise patient and public safety, maintain access to needed technologies, and support innovation. Input gathered through this exercise will inform how the agency prioritises future work on designation.

Relevance for BHTA members

For organisations engaged in standards and regulatory compliance, the consultation focuses on which medical device standards are relied upon to demonstrate conformity, and where changes to the designated list could improve alignment with current practice. Designated standards remain a recognised route to demonstrating compliance with essential requirements in Great Britain.

The deadline for responses to the MHRA’s open consultation is 30 September 2025. Respond online here.

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 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 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.