Contact Us On
020 7702 2141

BHTA spring conference 2023: Implementing the MedTech Strategy, tackling procurement inconsistencies, and understanding UK medical device regulations

BHTA spring conference 2023 image

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.

UK MedTech Strategy and implementation plan

David Lawson image

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.

Future direction of notified bodies in the UK

BSI Purvi Patel image

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:

  • New applications for UKCA certification for companies without any prior certification: BSI would follow the current directive processes it has but would account for the UK-specific requirements where relevant. BSI would look for the manufacturer’s UK-responsible person, the declaration of conformity, conformity to any UK-designated standards, and labels for the UKCA mark.
  • New applications for UKCA certification based on the directives or regulations issued by BSI’s EU notified body – BSINL: This would be a bridge process where BSI recognises that the firm has conformity assessments carried out by BSI Netherlands (BSINL), and it would look for UKCA-specific requirements. The exception for this is under the IVDR because the classifications for the IVDs between the directives and regulations have changed quite a lot, so BSI could not do much of a bridging process for this. However, BSI can implement a bridging process for medical devices.
  • New applications for UKCA certification based on the directives or regulations issued by a different EU notified body (not BSI): In this case, BSI follows the principles of notified body transfer which it operates when it reviews, and BSI would again look for the UK-specific requirements.

“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.

UK medical device regulations update

William Lee - BHTA's new Parliamentary and Policy Executive

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.