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The Medicines and Healthcare products Regulatory Agency (MHRA) has outlined the next stage of its medical devices regulatory reform programme, providing further details of its proposed Pre-market Statutory Instrument (SI) during a joint BHTA and AXREM webinar.
Speaking during the webinar, Dr Rob Reid, Deputy Director for Innovative Devices at the MHRA, explained how the proposed legislation aims to modernise the UK Medical Devices Regulations 2002 while balancing patient safety, innovation, and timely access to medical technologies.
The proposed reforms are designed to support safe and rapid access to medical devices through risk-proportionate and predictable routes to market, new International Reliance pathways, a UKCA framework focused on innovation, and closer alignment with international standards to support harmonisation and collaboration.
BHTA members who were unable to attend can watch the recording of the MHRA Pre-market Statutory Instrument webinar.
Dr Reid said reform is needed to respond to rapid technological advances, address recommendations from the Independent Medicines and Medical Devices Safety Review, and align the UK regulatory framework more closely with international best practice. These priorities also support the ambitions set out in the UK Government’s Life Sciences Sector Plan and the 10 Year Health Plan for England, both of which recognise the important role medical technology plays in improving patient outcomes and driving economic growth.
The Pre-market SI is one part of a broader programme of regulatory reform. It follows the introduction of strengthened post-market surveillance requirements, while further policy work is already underway on areas such as electronic labelling, clinical investigations, health institution exemptions, and the future regulation of software and artificial intelligence (AI).
Rather than replacing the UK MDR 2002, the draft SI makes targeted amendments to the existing regulations while leaving other areas unchanged.
The draft SI would introduce:
See the slide below for the draft future UK MDR 2002 structure:
However, Dr Reid emphasised that several parts of the regulations are not being amended through the current legislation. Clinical investigations, performance evaluations, health institution exemptions, Approved Body designation and oversight, certain conformity assessment procedures, systems and procedure packs, exceptional use provisions, and market surveillance powers will instead be considered as part of future phases of the MHRA’s wider reform programme.
The draft SI would also update key definitions relating to medical devices, implantable devices, and intended purpose, bringing them more closely into line with international approaches. The UK’s Essential Requirements governing safety, performance, and labelling would also be revised to align more closely with the EU’s General Safety and Performance Requirements (GSPRs), with modifications for the Great Britain regulatory framework. The MHRA intends to publish guidance and implementation checklists to support manufacturers.
The draft SI would strengthen technical documentation requirements, requiring manufacturers to maintain up-to-date, searchable technical documentation in English and make it available to the MHRA within three working days if requested, with flexibility for extensions where appropriate. Document retention periods would also increase to the longer of the device’s lifetime or 15 years for implantable devices, and the longer of the device’s lifetime or 10 years for non-implantable devices. These changes are intended to improve regulatory oversight and support more effective post-market surveillance.
The proposals would also strengthen traceability through mandatory Unique Device Identifiers (UDIs) and new implant card requirements. Manufacturers would provide implant cards and patient information leaflets, while healthcare providers would record device identifiers to support incident reporting, recalls, and long-term traceability.
Recognising the increasing role of software in healthcare, the draft SI also introduces Pre-Determined Change Control Plans (PCCPs), allowing certain pre-approved software updates without requiring a new conformity assessment, provided they remain within agreed parameters. New cybersecurity requirements would align more closely with international best practice by requiring manufacturers to minimise cybersecurity risks and provide appropriate information for users. Dr Reid confirmed that proposed changes to software classification have been deliberately deferred while the MHRA considers recommendations from the National Commission on the Regulation of AI in Healthcare.
The proposals would also expand the circumstances in which electronic instructions for use (eIFUs) may be used for certain devices, subject to appropriate risk assessments. Paper instructions would still be required where information is intended for patients.
The draft SI also updates requirements for custom-made devices, introducing stronger quality management and traceability measures for certain higher-risk implantable devices.
A key proposal is the introduction of International Reliance pathways, allowing the MHRA to make greater use of approvals granted by trusted regulators in the United States, Canada, and Australia. Rather than duplicating existing regulatory assessments, the new approach is intended to provide a more proportionate route to the Great Britain market while maintaining appropriate safeguards for patient safety.
Dr Reid explained why the European Union is not included within the proposed International Reliance routes. Following consultation with industry, the MHRA concluded that requiring Approved Body involvement for CE-marked devices could create additional barriers to market. Instead, the UK Government is considering the future recognition of CE marking separately, with a response to the consultation expected in due course.
The draft SI also introduces new provisions governing promotional claims and equivalence. Promotional material would be expected to be evidence-based, consistent with the device’s intended purpose and instructions for use, communicate relevant risks appropriately, and avoid misleading users. Manufacturers relying on equivalence would also be required to provide stronger technical, biological, and clinical justification to support their claims.
The draft Pre-market SI has now completed its 60-day notification period through the World Trade Organization (WTO). The MHRA is reviewing comments received during that process before finalising the legislation for introduction to Parliament later this year.
BHTA members can review the draft Pre-market Statutory Instrument on the WTO website.
Subject to parliamentary approval, the new regulations are expected to come into force around the middle of 2027. Alongside the legislation, the MHRA intends to publish detailed guidance and implementation materials to support manufacturers as they prepare for the changes.
The BHTA will continue to keep members informed as the legislation progresses and further MHRA guidance becomes available. BHTA members can access both the webinar recording and draft SI for further detail.
Introduction written by Dr Barend ter Haar, Director of BES Healthcare, a BHTA member
In the light of the failure of certain breast implants, the European MDD was replaced by the EU MDR a few years ago to strengthen safety considerations across all medical devices. The required technical files for medical CE marking have, as a result, needed to have much more clinically related data attached to them, and the risk elements have been strengthened. However, with any new lengthy legislation, inevitably some interpretations were or are not anticipated.
The EU MDR has one reference to combining products, in Clause 14.1: “If the device is intended for use in combination with other devices or equipment the whole combination, including the connection system shall be safe and shall not impair the specified performance of the devices. Any restrictions on use applying to such combinations shall be indicated on the label and/or in the instructions for use.”
In the world of wheelchairs, and wheelchair accessory provision, some wheelchair manufacturers have interpreted this clause to advise prescribers that they cannot attach after-market devices (such as back supports or other postural support devices (PSDs)) to their chairs as it would be unsafe without a ‘Combination Agreement’.
It is in consideration of the potential clinical restrictions and also the potential anti-competitiveness of this practice that the BHTA has taken legal advice and issued: ‘BHTA Policy Note – After-Market Wheelchair Accessories’. The reason that there is a strong after-market of PSDs is that the clinical needs of wheelchair users are so very varied that novel solutions have often been developed to cover many of the more specialised needs where the original wheelchair and its proprietary accessories do not meet the occupant’s needs satisfactorily.
The issue is complex in that all manufacturers need to protect not only their own interests (both commercial and risk management), but also the interests of the chair occupants (safety in particular). But the level of risk can vary a great deal between different potential accessories, and different use environments. Clearly there is a big difference in the risk between applying a simple seating accessory compared with, for example, a powered add-on device that lifts the front casters, generates speeds of up to 15 km/h, and enables access to terrain previously not possible in the original manual wheelchair.
Manufacturers’ blanket restrictions are counter to fair competition and can impede optimal outcomes for end users. At a minimum, the use of third-party accessory types deemed as low risk should not be restricted without justification. On the other hand, employing a system of combination agreements or approved compatibility helps manufacturers to mitigate the risk of incidents before, rather than after they occur. However, with the number of combinations of after-market accessories available it is not practical for all combinations to be anticipated and be covered by combination agreements.
Within the EU MDR, where a manufacturer produces an after-market accessory which they proscribe as being a medical device, it falls on that manufacturer’s risk management processes to identify circumstances where their device cannot safely be combined with another device, and provide this in their IFUs.
Another ‘grey’ area lies around modular devices. To resolve this (covering both modular devices and after-market accessories), the EU Medical Device Coordination Group has published a guidance document that defines sub-types of medical devices. One of these is “adaptable medical devices” (see MDCG 2021-3 Q & A on Custom-Made Devices, March 2021). This includes: “Note 1: Adaptable medical devices (products which fall under (a) above) are mass-produced medical devices which must be adapted, adjusted, assembled or shaped at the point of care, traditionally by a healthcare professional, in accordance with the manufacturer’s validated instructions to suit an individual patient’s specific anatomo-physiologic features prior to use. Examples of mass produced adaptable medical devices may include:
The attached BHTA Policy Note – After-Market Wheelchair Accessories contains the legal advice provided to the BHTA on this subject, and offers guidance as to what restrictions a manufacturer can or cannot make around the combination of different manufacturers’ products. The Policy Note specifically references Wheelchairs, but the issues are as relevant for other medical device combinations such as those listed above, or, for example, combining after-market mattresses with medical bed frames.
Click here to download the After-Market Wheelchair Accessories note as a PDF.
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.
Recently, leading medtech suppliers had the chance to attend the British Healthcare Trade Association (BHTA) conference, ‘UK Health and Social Care Landscape: How will UK policy decisions impact patient experience?’.
Both BHTA members and non-members were invited to the spring conference to discover how current policy decisions are shaping the future of health and social care, impacting UK patients, and what this change means for businesses.
Sponsored by Verlingue, the sell-out conference took place on 11 May 2023 at the Manor Hotel in Meriden, Solihull.
The conference saw an impressive roster of senior government and sector leaders present engaging sessions throughout the day to suppliers about future policy directions, new UK Government priorities, and how collaboration and innovation will ultimately improve the patient experience.
Attendees gained invaluable insights into the changing health and social care landscape, asked questions to the high-profile speakers, and networked with key stakeholders and peers.
Below are the highlights from the afternoon sessions from David Lawson, Director of MedTech; Purvi Patel, BSI Regulatory Lead for Medical Devices & IVDs; and William Lee, BHTA Head of Policy & Compliance.
Topics in these sessions included tackling procurement inconsistencies, keeping up government engagement with the medtech industry, and the complex UK regulatory landscape regarding medical devices.
The first set of morning presentations from David Stockdale, BHTA CEO; Steven Ferguson, Head of Market Access at IQVIA; and Paul Gaffney, Director of Tendo Consulting, can be found here.
These sessions explored how the BHTA is successfully lobbying on behalf of its members, how tackling NHS waiting lists with innovative technology is a priority, and how the changing political landscape is impacting healthcare policy.
The second set of morning talks from Simon Williams, Local Government Association Director of Social Care Improvement, and Alan Wain, COO at EPSCOT can be read here.
These presentations looked at social care reform, how better use of technology could improve the lives of millions of social care users, and how social value in public procurement impacts suppliers.
David Lawson, Director of MedTech, discussed the UK MedTech Strategy and its implementation plan.
He reinforced a key theme that was discussed throughout the conference: that innovation adoption within the healthcare sector is an immediate priority. There is lots of opportunity in medtech and a sense of urgency in the sector to tackle NHS issues.
“When I’ve spoken to people in the industry, NHS England, NHS Supply Chain, MHRA, NICE, and life science, my sense is there’s a general consensus about what the challenges are in medtech,” he commented. “There’s also a consensus about potential solutions. The challenge is trying to get things done.”
David reflected on what he presented at the BHTA Integration and Sustainability Conference 2022 in September last year. One of the things he discussed at that event was about a commitment to industry engagement from the Department of Health and Social Care (DHSC).
“I feel that has been quite positive for me to get different views, meeting with different suppliers, and meeting with the BHTA numerous times,” he said. “I’m keen that I keep that engagement up.”
The UK Government’s priorities are technology as an enabler and the importance of the life science industry. David highlighted that the Secretary of State sees medtech as a key priority and a solution to the NHS’ challenges, especially in regard to innovation adoption. The government also sees medtech and life sciences as an opportunity for growth in the economy.
“If we look at the Autumn Statement from last year, the Chancellor announced additional funding for MHRA to support them under their regulatory reform work and provide immediate access in terms of innovation,” he explained. “It’s unusual for a chancellor to talk about medtech in an Autumn Statement, but it reflects the fact that politically medtech has got quite a lot of momentum behind it.”
David noted challenges have been raised by industry around procurement inconsistencies, such as social value, inflation, and net zero. This is creating frustration within industry, as it means suppliers have to keep taking different approaches to tenders.
A key catalyst for improvement in this area, he said, is the NHS Central Commercial Function (CCF). He pointed towards Jacqui Rock, who is the chief commercial officer for NHS England and the CCF.
“There is a lot of leadership now in the system at that level that recognises these challenges and wants to engage and sort them out,” he continued. “Jacqui’s been having forums around SMEs, social value, and other areas. Jacqui is in an ideal position to drive improvement across the procurement landscape.”
David added that there is an issue with adopting innovation at scale in the NHS.
“This is an area of genuine frustration when you’re shown around hospitals where there’s great medtech solutions and you ask when they’re being deployed across the country and they don’t have an answer,” he explained. “We’re passionate about solving the adoption problem.”
He also recognised that the innovation pipeline for medtech is not joined up and there is a lack of clarity about what the process is. This is an area of particular focus for getting greater clarity of the process in terms of innovation adoption.
“For new innovations coming through,” he added, “how do we assess them and how do we make informed decisions? Once we’ve made the right impact, how do we get through levels of reimbursement and adoption?
“For solutions already on the market, how do we make important decisions about assessment and clarify the adoption of the most effective products in the market?”
David also delved into the MedTech Strategy, emphasising that it is centred around the vision of “right product, right price, right place”.
“The right product is about what is the most effective product to use?” He commented. “The challenge with medtech is that there are half a million medical devices being used in the UK. How do we measure what is the most effective products to use?
“Right price is about value-based healthcare. How do we understand the impact of products on patient outcomes? How do we get consistency across this area?
“Right place is partly about resilience but also about equity to access as well.”
The delivery of the strategy is led by different agencies: NICE, DHSC, NHSE, NHS Supply Chain, and MHRA. David said a key goal is about aligning this collaborative work across the agencies.
He explained: “For example, product evaluations are led by NICE. What we want to do is make sure there’s a connection between what NICE do with NHS England from a commissioning perspective but also if there are class-based evaluations impacting on products that NHS Supply Chain manage that the outcomes of those assessments feed into the category strategy and relations that the supply chain has. Otherwise, what’s the point in doing it? It’s about having a joined-up approach to tenders.”
David also discussed the strategy’s part IX tariff and its three areas of focus: the ability to review listed products, the assessment process to list products, and prescribing practice (second phase). A targeted consultation is due to come out at the end of July 2023 on part IX of the MedTech Strategy.
Purvi Patel, BSI Regulatory Lead for Medical Devices & IVDs, spoke about the UK regulatory landscape regarding medical devices.
She said that Brexit has had a big impact on the UK medtech regulatory landscape. Placing a medical device on the GB market with the UKCA mark is now mandatory from 1 July 2025; anything that is CE-marked and placed on the UK market is valid until 30 June 2025, after that point, medical devices need a UKCA mark.
“That’s through registration with the MHRA, having a conformity assessment done through an approved body, and then you’re able to place your device on the GB market,” commented Purvi.
“If we look at Northern Ireland, the route BSI offers for placing medical devices on this market, as an approved body, is the CE mark. There is something called the CE+UKNI mark. That’s not something that BSI offers because the UKNI mark isn’t recognised by the EU.”
She continued: “There was a change in March 2023. The European Journal published a legislation – 2023/607 – and this is dealing with those devices that have been certified under the directives having an extension granted with the timelines of 31 December 2027 for Class III devices or IIb implantables that are not well established technology, which are allowed to be, under the directives, on the market until 30 June 2028.
“So we have the EU timelines with what’s valid under the directives up until 2027/2028, but then we also have now the UK legislation saying that we have until the 30 June 2028 for medical devices complying with the new UK legislation. Then 30 June 2030 by which we need to have IVDs complying with the new UK legislation.”
This has caused complexity for medical device manufacturers around: what they need to do with their directive certificates, because they’ve got extended validity now based on certain conditions; what to do with devices that are certified under current UK legislation; and thinking about future UK legislation and timelines.
“To place devices on the UK market, you need to have registration with the MHRA, a declaration of conformity, UK designated standards, an appointed UK responsible person, and labels showing a UKCA mark or CE mark,” she added. “Those are the extra UK requirements.”
Purvi helpfully explained what conformity assessment looks like for UKCA at BSI and detailed various scenarios:
“The other two options are if you combine the applications,” Purvi continued. “We do see applications where manufacturers have got their MDR assessment in and they’re formally applying for a UKCA certification at the same. We would follow the MDR certification processes look for the UK-specific requirements as well – we’d assess that at the same time – so we’d do things like combine the QMS audits and combine microbiology audits.
“The final scenario is if you’ve got a combined application with UKCA with IVDs – so if you’ve got a certificate under the IVDR and you’re looking for UKCA certification, which we’d leverage off the IVDD – we’d combine the QMS audits and the microbiology audits, but we’d have to do standalone technical documentation reviews because of the differences in classification with the IVDs between the directives and regulations.”
Purvi explained that there are three lists of designated standards in the UK: medical devices, IVDs, and active implantable medical devices. These standards can be found on the UK Government website.
She then discussed UKCA placement on medical devices.
In Great Britain, UKCA placement needs to be on the device or on the sterile pack (where appropriate), any sales packaging for the device, and instructions for the device. For products being placed in Northern Ireland and the EU as well as in Great Britain, both the CE mark and UKCA mark will need to be placed on the medical device.
Importantly, she reminded firms that they need to approach BSI as early as possible when getting devices UKCA marked because it is very busy and capacity is not limitless.
The last presentation of the day was delivered by William Lee, BHTA Head of Policy & Compliance.
He noted that while the MHRA aims for new medical device regulations to be in place for 1 July 2025 in its guidance, this date does not appear in statutory instruments (SIs).
Bill also discussed medical device transitional arrangements.
“The transitional arrangements have changed slightly,” said Bill. “CE-marked devices under the EU MDR can, under certain conditions, stay on the GB market until the new regulations take effect, i.e., 1 July 2030. It seems clear that MHRA intends to make a further change that would mean that you needed to apply the phrase ‘whichever is sooner’ under the EU MDR.
“Similarly, medical devices CE-marked under the EU MDD can stay on the GB market for three years, under certain conditions, after the regulations take effect, which takes us up to 2028.
“Our understanding was that the previous transitional arrangements applied to all classes of medical devices.
“I think the biggest change and the most relevant change for BHTA members is that for Class I products that do not require third-party conformity assessments – so standard Class I products that aren’t sterile, don’t have a medical function, and that aren’t reusable surgical instruments – the new transitional arrangements will not apply. These Class I products will need to comply with UK regulations and display the UKCA mark from the new date of inception.”
Bill explained that the SI has been laid before the House of Commons and the House of Lords in a draft affirmative. If the medical device SI is approved, it passes into law on 30 June 2023.
BHTA is currently seeking clarity from MHRA regarding the 1 July 2025 inception date, Class I device transitional arrangements, labelling requirements, and securing MHRA guidance webinars for members.
The association will issue a guide to BHTA members on UK medical device regulation and laws in the coming weeks.