- Back
- Back
- Back
- Back
- Back
- Back
- Back
- Back
- Back
- Back
NHS Supply Chain (NHSSC) outlined tender requirements and plans to simplify supplier trading processes at its webinar on 7 October 2026. The session addressed documentation issues affecting bids, progress towards its 2030 strategy, and changes suppliers can expect through its modernisation programme.
As a condition of participation in NHSSC tenders, bidders must submit valid, in-date ISO 9001:2015 or BS EN ISO 13485:2016 certification, or Medical Device Single Audit Program certification, accredited by UKAS or one of the accepted alternative Notified Bodies.
If certification is being obtained, bidders must provide a letter from the relevant body confirming that the process has started and that the estimated outcome following audit is within two weeks of the assessment summary being issued, as detailed in the tender timetable. Committing to obtain certification is not sufficient; failure to provide evidence will result in the bid being rejected.
Certification must include, but not be limited to, sales, manufacturing, storage, and distribution. If bidders do not cover all activities themselves, for example because they are distributors or use key contractors, they must provide ISO certificates for every company involved with their bid submission.
For medical devices, bidders must provide conformity assessment information at tender submission. UKCA and CE marking indicate conformity with the applicable medical device requirements. CE marking remains recognised in Great Britain subject to the relevant requirements and timelines.
A Declaration of Conformity must link the products tendered to the relevant certification and regulations. Supplier product codes that differ from the manufacturer’s Declaration of Conformity require an explanatory document linking the codes.
Medical devices must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) before being placed on the Great Britain market. Registration supports traceability and product safety, alongside Global Medical Device Nomenclature (GMDN) codes for identifying and classifying devices.
MHRA registration does not constitute accreditation, certification, approval, or endorsement. NHSSC therefore requires supporting regulatory documentation at tender.
NHSSC’s 2030 strategy brings together Supply Chain Modernisation, Commercial Transformation, and Trading Transformation to improve supply services, purchasing, and trading processes.
The Trading Transformation update covered work to simplify pricing and reduce invoice queries. Progress on the programme so far included removing 75,000 unsold products from the catalogue, eliminating 1.1 million price points, and introducing pricing dashboards and revised customer segmentation.
Next steps include further reviews of quantity-based price bands and units of issue, meaning the quantities or pack sizes in which products are supplied. The price banding review initially targeted bands with no orders during the previous 12 months. NHSSC aims to complete its three-phase price banding review by March 2027, retaining bands where needed for competitive pricing and appropriate units of issue.
A pilot with two eDirect suppliers, which deliver directly to customers, is testing how to manage invoice and purchase order mismatches where delivered quantities exceed those ordered.
NHSSC is also reviewing its IT systems to establish Oracle as the single source of pricing data, simplify pricing structures, and increase automation. Delivery is provisionally targeted for spring 2027.
The programme involves investment in NHSSC’s network, technology, and working practices, with phased implementation intended to minimise disruption.
Intended supplier benefits include improved demand visibility, standardised processes, better data quality, and simpler transactions. NHSSC committed to early engagement and proactive communication, with opportunities to shape and test changes.
Suppliers will be expected to prepare for system and process changes, support improved data standards, and work collaboratively to maintain supply.
Further information is available in NHSSC’s supplier factsheet on the modernisation programme.
BHTA member Reliance Medical is recalling certain batches of its TraumaFix Professional and Tactical Pelvic Splints because the hook and loop strap has been assembled incorrectly.
The urgent Field Safety Notice, dated 30 September 2026 and published on the MHRA website, also covers affected splints supplied within specified batches of TraumaFix FREC (First Response Emergency Care) 3 Kits and refills.
The splints are intended for the emergency treatment of suspected pelvic fractures. The incorrectly assembled strap cannot be secured to the splint as intended, preventing full immobilisation of the pelvis.
Reliance Medical states that the fault affects every device in the listed batches.
The fault may delay treatment while the user seeks a way to secure the strap. If no solution is identified, treatment will have reduced efficacy.
The notice describes three responses a user might attempt: twisting the strap, which may limit tightening; tucking it in, which risks loosening; or rethreading it, which restores effectiveness but is not immediately obvious and takes additional time. These are scenarios considered in the risk assessment; the required action is to return affected devices.
Ineffective tightening may fail to control internal haemorrhage. Reliance Medical considers the risk unacceptable.
The notice does not recommend patient follow-up or review of previous results, and states that communication of the FSN to patients or lay users is not required.
Users and distributors should check product references and lot numbers against the following details.
| Product | Reference | Affected lots |
| TraumaFix Professional Pelvic Splint | 11007 | 3629, 3668 |
| TraumaFix Tactical Pelvic Splint | 11008 | 3630 |
| TraumaFix FREC (First Response Emergency Care) 3 Kit | 10048 | 628070, 625022 |
| TraumaFix FREC (First Response Emergency Care) 3 Kit (Refill) | 10048/R | 625062 |
Reliance Medical instructs recipients to identify and return affected devices. For affected FREC 3 Kits and refills, only the pelvic splint needs to be returned. The notice specifies a three-month timeframe for both user actions and the manufacturer’s recall.
A customer reply is required. The acknowledgement form in Appendix 1 requests confirmation of receipt, affected lot details, and quantities sold and held in stock. It also asks distributors to confirm that they have notified affected customers and will arrange collection for return to Reliance Medical.
Users and distributors with questions about the notice or return arrangements can contact Reliance Medical on 08456 448808 or at FSN@reliancemedical.co.uk.
The notice should be shared with those who need to be aware within affected organisations and any organisation to which potentially affected devices have been transferred. Recipients are asked to maintain awareness of the notice and resulting action for an appropriate period to support the corrective action’s effectiveness.
Device-related incidents should be reported to the manufacturer, distributor, or local representative, and to the national competent authority where appropriate.
Full product identification details, required actions, and the acknowledgement form are available in the Reliance Medical Field Safety Notice.
The UK Government has announced enhanced collaboration between the Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA).
The collaboration is intended to accelerate innovation, strengthen patient safety, and reduce barriers to transatlantic market access for medical technologies and AI.
The MHRA will deepen its regulatory collaboration with the FDA, with a shared ambition to advance alignment and reciprocity.
During the Advanced Medical Technology Association conference in San Diego, MHRA Chief Executive Lawrence Tallon highlighted the agencies’ commitment to accelerating joint initiatives and policy development, supported by strategic opportunities for cooperation.
The MHRA has launched the National Commission on the Regulation of AI in Healthcare, bringing together UK and international experts, including contributors from the United States. The commission will develop recommendations to support the safe and transparent use of AI-driven medical technologies and to contribute to international alignment.
The agency has also confirmed plans for new international reliance routes designed to improve international investment and increase UK access to medical devices that have already been approved by trusted regulators, including the FDA.
According to the announcement, the reliance framework is intended to include products cleared through the FDA’s 510(k), De Novo, and Premarket Approval (PMA) pathways.
For BHTA members operating in the UK and internationally, the planned international reliance routes are expected to facilitate faster UK market access for devices already approved by trusted regulators.
The strengthened collaboration between the MHRA and FDA, together with the establishment of the National Commission on the Regulation of AI in Healthcare, signals ongoing work to align approaches to regulating medical technologies and AI.
The medtech regulatory reforms in Great Britain are intended to enter legislation in 2026 and open new reliance routes from 2027.
The Medicines and Healthcare products Regulatory Agency (MHRA), working with the Department of Health and Social Care, ran a call for evidence to inform its statutory review of the UK medical device regulatory framework.
The consultation received 123 responses from industry, trade associations, healthcare professionals, patient groups, and charities. To learn more about the consultation and see the BHTA’s full response, read this article.
As part of this work, MHRA held a workshop with trade associations, including the BHTA, to share early analysis from the responses and invite further input from stakeholders.
The figures below summarise the initial responses from stakeholders to the MHRA consultation.
When asked – How well do you think the current UK medical device regulatory framework protects public health? – most felt it offers protection to some degree, with 40 percent selecting ‘somewhat effectively’ and 35 percent ‘effectively’. A further 12 percent said ‘very effectively’. Five percent answered ‘ineffectively’, and seven percent were ‘not sure’.
To the question – On a scale where 1 = not at all effective and 10 = extremely effective, how effective are the regulations in practice? – scores clustered in the mid‑to‑high single digits, with the largest share around six to seven, and relatively few at the extremes. This indicates a broadly moderate view of day‑to‑day effectiveness.
See the slide below for views on unnecessary or excessive regulatory burdens and whether stakeholders have encountered any issues, blockers, or areas of ambiguity when using the regulations.
To the question – On a scale where 1 = not at all clear, well‑structured, or easy to navigate, and 10 = extremely clear, well‑structured, and easy to navigate, how would you rate the framework? – responses typically centred around six, with relatively few at the extremes.
When asked “Are there any overlapping, duplicative, or outdated provisions in the framework?”, 47 percent said ‘yes’, 42 percent ‘no’, and nine percent were ‘not sure’.
Views were cautious when asked: “Do the regulations provide the appropriate balance of flexibility to respond to new technologies or emerging public health issues, and robust regulatory oversight?” 42 percent disagreed and 11 percent strongly disagreed; 27 percent neither agreed nor disagreed; 17 percent agreed; and two percent strongly agreed.
Responses to the question – Do you think the current balance between what is set out in legislation and what is provided in supporting guidance appropriate? – received mixed responses. 19 percent answered ‘yes’. 28 percent felt too much sits in legislation, 21 percent felt too much sits in guidance, and 42 percent were unsure.
See the slide below for stakeholders’ views on streamlining medical device legislation.
On behalf of member companies, the BHTA welcomed MHRA’s engagement and added two pragmatic suggestions in the session:
According to discussions with MHRA, there will be further stakeholder workshops in October.
Findings from the survey and these workshops will inform the review, with a report expected early next year; all feedback will be anonymised in the final report.
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 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.
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.”
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:
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.
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.
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 Medicines and Healthcare products Regulatory Agency (MHRA) has published an updated response to its consultation on statutory fees for medical devices, confirming that a new annual registration fee to support post‑market surveillance (PMS) activities will take effect from 1 April 2026. This article summarises the changes for BHTA members.
From 1 April 2026, an annual medical device registration fee will be charged per Global Medical Device Nomenclature (GMDN) level 2 category under which a manufacturer has registered products. Where no level 2 exists, level 1 will apply.
The MHRA has confirmed that this new fee will replace the current one‑off medical device registration fee and will be calculated on the categories recorded on 1 April each year, with pro‑rata charges for any new categories added mid‑year.
The MHRA has indicated an estimated amount of £300 per category from 1 April 2026 per GMDN level 2 category (or level 1 category where no level 2 exists), and has noted that approximately 60 percent of manufacturers are expected to pay a single charge.
See the updated response, published 2 September 2025, for more information: ‘MHRA consultation on statutory fees — proposals on ongoing cost recovery: updated government response’.
The one‑off device registration fee remains in place until 31 March 2026. Current schedules, including the £261 medical device registration fee, are set out on the ‘Current MHRA fees’ page.
In its original consultation, published on 29 August 2024, the MHRA proposed an annual medical device registration charge modelled at £210 per GMDN code to fund PMS activities. Feedback from industry, including trade associations, questioned affordability and fairness across different device portfolios.
The revised approach, set at GMDN level 2, is intended to distribute costs more equitably while maintaining patient safety and supporting innovation. The consultation documents and background are available at ‘MHRA consultation on statutory fees — proposals on ongoing cost recovery’ and in the original consultation paper ‘MHRA consultation on statutory fees’.
Under the updated model, a manufacturer will pay once per relevant GMDN level 2 category for the charging year from 1 April to 31 March. If additional categories are added during the year, the charge for those categories will be applied on a pro‑rata basis for the remainder of the year.
Before billing begins, the MHRA will invite manufacturers to take part in a data‑cleansing exercise so they can remove obsolete or withdrawn products from the register without charge. Further guidance will be published by the MHRA to explain scope, billing mechanics, and preparation steps, according to the organisation.
The MHRA has stated that fees will continue to be paid through the Device Online Registrations System (DORS). BHTA members should ensure internal payment processes are ready for the new annual billing cycle.
At the recent British Healthcare Trades Association (BHTA) and AXREM conference, Dr Rob Reid, Deputy Director of Innovative Devices at the Medicines and Healthcare products Regulatory Agency (MHRA), delivered the first part of a pivotal talk titled ‘Regulation in the Medtech Sphere’.
Titled ‘The Future of MedTech – Innovating for Tomorrow’, the conference was held on 13 May 2025 at The Mercure, Northampton.
Rob’s presentation provided valuable insights into the UK’s evolving regulatory landscape and what medtech companies must prepare for in the coming months and years.
The UK’s current regulatory framework, the Medical Device Regulations (MDR) 2002, is outdated and in need of an update, Rob explained. MHRA’s regulatory update aims to align the UK’s framework with advances in technology, international standards, and recommendations from the Cumberlege review.
Central to the reform effort are three priorities: public and patient safety, support for innovation and growth, and closer alignment with international regulatory partners.
The MHRA’s updated medical devices regulatory road map, published in December 2024, divides the work into four key blocks: post-market surveillance, pre-market requirements, policy development, and software and AI. Of immediate relevance to the medtech sector is the introduction of new post-market surveillance (PMS) regulations, which come into force on 16 June 2025.
Rob emphasised the critical role of PMS in ensuring safety and enabling faster, yet responsible, market access.
Historically, PMS requirements under UK MDR were set out in guidance rather than legislation, resulting in inconsistent compliance. “We had some companies that were doing a very good job… and others that weren’t,” Rob stated. By introducing PMS into legislation, the MHRA aims to level the playing field and ensure higher safety and performance standards.
The new PMS regulations will apply to all medical devices placed on the market or put into service in Great Britain from 16 June 2025. This includes devices approved via CE marking or the Northern Ireland Protocol, although there are limited exemptions (e.g. for custom-made devices and those used in clinical investigations).
Key features include:
Manufacturers must implement a PMS system based on a detailed PMS plan, covering incident reporting, feedback collection, and corrective actions. As Rob noted: “It’s not just safety that matters… post-market surveillance provides the opportunity to monitor performance in the real world.”
The second priority area is the forthcoming premarket regulations, which are currently being finalised following consultation. These will focus on essential changes, including:
This last point marks a significant shift. The UK will begin recognising approvals from trusted regulators such as Australia, Canada, the EU, and the US, with implementation of international reliance pathways expected from mid-2027. Rob explained: “This will effectively be the long-term response or solution in terms of international reliance.”
These regulatory updates are expected to be laid in Parliament by the end of 2025, subject to legislative scheduling, with some measures entering force by mid-2026.
The MHRA recognises that regulation must evolve alongside rapid technological advancements. For areas like AI and software, the agency is prioritising agile, guidance-led approaches rather than rigid legislation. Rob highlighted the UK’s international leadership in this area and initiatives like the AI Airlock, a regulatory sandbox designed to help innovators navigate approval pathways.
Additional future enhancements under consideration include policies for early access to devices, sustainability, remanufacturing, and health institution exemptions. The MHRA is also developing a fee-based scientific and regulatory advice service for companies with complex regulatory challenges.
BHTA members and the wider medtech community were encouraged to engage with the new PMS guidance, prepare for compliance, and stay informed as the MHRA rolls out the next stages of medical device regulatory reform.
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.
At the recent British Healthcare Trades Association (BHTA) Conference 2024, Laura Squire, Chief Healthcare Quality & Access Officer at Medicines and Healthcare products Regulatory Agency (MHRA), discussed where UK medical device regulation is at now and what the future looks like.
The BHTA Conference 2024 focused on the UK healthtech landscape over the next five years. It was a chance for BHTA members to hear from senior government and NHS speakers about how the changes made today will impact the future of the health service.
Laura began by explaining the MHRA’s purpose in delivering the future regulatory framework of medical devices in the UK. Its goal is to deliver a robust and leading regulatory framework that prioritises patient and public safety. In delivering this regulatory framework, the MHRA’s chief goals are to deliver:
The new regulatory framework has been implemented via a series of Statutory Instruments (SIs), Laura explained. Further details are in the slide below.
Laura also provided details of where MHRA is at now with UK medical devices regulation and plans for 2024-2025. The slides below provide more information.
“We’re trying to be more transparent about our timescales,” Laura commented. “But it’s very difficult to be transparent about timescales when you’re doing legislative work, because there are certain things that are not within our gift in terms of timescales.”
A key point from Laura’ presentation was around international recognition. MHRA recently published a statement of policy intent, which outlined MHRA’s intention to recognise medical device approvals from Australia, the EU, Canada, and USA. It contained further details for the access routes depending on the device type, class, and prior approval.
“We are also working actively with Japan to bring them into the international recognition,” added Laura. “It’s slightly more complex there because of the population and understanding how they apply some of the international standards, but there is no doubt that Japan is a rigorous regulator, so we would trust it.
“We’re calling these comparable regulators, because I don’t like the phrase ‘trust’. It implies we don’t trust everybody else, and we do trust quite a lot of other regulators. It’s about the practicalities of making it work. At the moment, these countries are the ones that we think we can get to work, and we’ve worked with all these countries to try to design the framework.”
MHRA is testing the proposed framework in collaboration with industry and approved bodies, using a range of devices with existing approvals from these countries. Market access via international recognition would only be formally granted once the future core regulations are in force, Laura explained. The proposed framework may be updated based on these activities.
The Medicines and Healthcare products Regulatory Agency (MHRA) published a statement of policy intent for international recognition of medical devices on 21 May 2024.
Entitled ‘Statement of policy intent: international recognition of medical devices’, it describes how the UK Government intends to recognise regulatory approvals from Australia, Canada, the European Union, and the United States of America depending on device type, class, and prior approval.
The MHRA continues to review the list of comparable regulator countries and is in active discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) to explore the recognition of medical device approvals from Japan.
The MHRA’s statement of policy intent focuses on ensuring safe access to quality-assured medical devices and reducing the duplication of assessments by comparable regulators to enable resource to be focused on more innovative products for the benefit of patient health. This statement will also allow manufacturers to start considering whether their devices will be eligible for the proposed alternative routes to market.
The proposed framework is still in draft, and the final version would be integral with the future core regulations.
Dr Laura Squire, Chief Quality and Access Officer of the MHRA, said: “Today’s announcement is an important step forward towards a robust MedTech regulatory framework that prioritises patient safety, gives patients access to the medical devices they need and ensures the UK remains an attractive market for medical technology innovators.
“We will continue to work on how our intended policy on international recognition of medical devices will operate in practice. By sharing the draft policy now, we aim to give greater clarity about the MHRA’s future direction of making regulatory approvals simpler, where it is safe to do so. At the same time, we remain fully committed to the UKCA marking for medical devices.
“We continue to expand capacity in UK Approved Bodies and to work to ensure UKCA marking supports safe and earlier access to the most innovative and transformative medical products.”
To be eligible for the proposed framework, medical devices will need to:
The proposed framework would provide a certificate of international recognition that will grant devices access to the Great Britain market but would not provide a UKCA marking or UKCA certification. MHRA underlines that manufacturers of medical devices would still have the option to use the UKCA marking to place devices on the Great Britain market.
The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies, delivering increased capacity for the certification of the performance and safety of medical devices.
LNE-GMED UK and Scarlet NB UK join the seven current UK Approved Bodies, increasing capacity for the certification of medical devices in the UK.
LNE-GMED UK has been designated as a UK Approved Body to assess and certify general medical devices in accordance with Part II of the UK Medical Devices Regulations 2002. Scarlet NB UK has been designated with a focus on assessing and certifying software and AI as a medical device (AI/SaMD).
This comes after two of the existing UK Approved Bodies had their scope expanded, with UL International UK now designated to assess and certify general medical devices (in addition to in-vitro devices), and TÜV SÜD now designated to assess and certify active implantables (in addition to general medical devices).
Before appointing an Approved Body, the MHRA conducts a detailed assessment process to ensure that organisations are stable and able to undertake impartial and objective conformity assessment activities; have an appropriate quality management system; and have the capacity and competence to undertake assessments and the processes they use meet the relevant regulatory requirements.
After successful designation, the MHRA monitors UK approved bodies’ activities including by regular audits and by witnessing some of their audits of manufacturers.
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.