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Regulation in the medtech sphere: NICE outlines updated approach to evaluation and guidance

Regulation in the medtech sphere: NICE outlines updated approach to evaluation and guidance

Presented by Anastasia Chalkidou at ‘The Future of MedTech – Innovating for Tomorrow’, hosted by the British Healthcare Trades Association (BHTA) and AXREM on 13 May 2025 at The Mercure, Northampton.


Anastasia Chalkidou, Programme Director for Healthtech Guidance Delivery at NICE, delivered a clear message to delegates at this year’s BHTA and AXREM conference: medtech innovators now have more opportunities than ever to engage with NICE’s updated and more transparent evaluation processes.

Anastasia Chalkidou, Programme Director for Healthtech Guidance Delivery at NICE image
Anastasia Chalkidou, Programme Director for Healthtech Guidance Delivery at NICE

Speaking during the second part of an engaging talk titled ‘Regulation in the Medtech Sphere’, Anastasia provided a high-level overview of the organisation’s transformation and its implications for the healthtech industry.

The first part of the talk was delivered by Dr Rob Reid, Deputy Director of Innovative Devices at the MHRA, which focused on the upcoming UK medtech regulations.

Over the past three years, NICE has undertaken a major transformation, which Anastasia explained is built on three core pillars: producing guidance that is more timely, more relevant, and has greater impact. For industry, this means a simplified and more accessible evaluation programme, with increased capacity and flexibility, and guidance that is better aligned with NHS system needs.

“We now have an early value assessment. That has become business as usual since last 12 months,” said Anastasia. This approach allows NICE to evaluate promising medtech, digital, AI, and diagnostic technologies sooner. These early assessments give conditional recommendations, provided there is a plan in place for further evidence generation, developed in partnership with stakeholders.

This marks a departure from the previous single technology evaluation model. With early value assessments, NICE is tackling the challenge of evaluating multiple products serving the same purpose. Now, NICE is able to make recommendations across groups of technologies, reflecting real-world usage and procurement within the NHS.

Another important development is NICE’s Prioritisation Board, which has now been operating for a year.

“It comes with a framework that explains in detail how we work on topic intel, the type of requirements that something needs to fulfil to be selected for evaluation with NICE,” explained Anastasia.

Decisions made by the board are publicly available and open to challenge, and NICE actively encourages input from clinicians and manufacturers to suggest technologies for evaluation as well as challenge certain decisions.

The HealthTech Evaluation Programme has seen notable growth. NICE’s digital health programme has also expanded significantly, with a threefold increase in evaluated products. NICE has also harmonised its processes with the publication of its unified healthtech manual, launched in March 2025, now moving into full implementation.

This harmonisation replaces fragmented and inconsistent evaluation methods with a single framework tailored to different types of technology. It promises more consistent timelines, enhanced support for evidence generation, and better alignment with wider NHS priorities. “It’s much easier now to access with fewer restrictions, greater capacity, and more flexible methods,” said Anastasia.

Beyond earlier and broader evaluations, NICE is piloting a late-stage assessment model. This focuses on high-spend, high-variation technologies already on the NHS procurement list, to determine whether pricing is justified and whether incremental innovation warrants broader adoption. This approach, said Anastasia, aims to ensure NICE “looks at incremental innovation and whether the price variation is justified”.

NICE’s transformation was shaped by early insights from the health system, which identified key needs: earlier signals of which technologies meet system priorities, more evaluations of digital solutions, and guidance on technologies already in market. NICE’s current programmes directly respond to these, providing earlier and more useful information for procurement, investment, and strategic decisions.

The message for industry is clear: whether a product is at the R&D stage or already in use, NICE now offers multiple routes for evaluation, conditional recommendation, and eventual system-wide adoption.

For BHTA members, NICE’s transformation presents a timely opportunity to engage with NICE earlier, more effectively, and with greater clarity on how products can achieve both recognition and adoption across the NHS.

See some of the slides from Anastasia’s presentation below:

Anastasia Chalkidou presentation slide image
Anastasia Chalkidou presentation slide image
Anastasia Chalkidou presentation slide image

BHTA conference about the future of medtech described as “informative” and “extremely interesting”

BHTA conference about the future of medtech described as “informative” and “extremely interesting”

On 13 May 2025, the British Healthcare Trades Association (BHTA), in coordination with AXREM, hosted a conference about the future of medtech, offering valuable and informative talks for attendees.

‘The Future of MedTech: Innovating for Tomorrow’ brought together BHTA and AXREM members to hear from senior leaders and experts from across the NHS, DHSC, MHRA, and more to explore the latest advancements and strategies in medtech.

Taking place at the Mercure Northampton, delegates had the chance to network with industry peers, get involved in engaging panel discussions, and learn about some of the most important topics in the medtech sector today.

Engaging presentations throughout the day included topics on sustainable procurement, how suppliers can meet the NHS’ net zero targets, the economic outlook for UK manufacturers, the future regulatory framework for the UK medtech sector, the DHSC’s upcoming work on building a MedTech Compass, and more.

BHTA Conference 2025 image

Speakers throughout the day were:

  • David Lawson, Director of Medical technology & Innovation at DHSC
  • Alexandra Hammond, Associate Director, Net Zero & Sustainable Procurement for NHS England
  • Dr Rob Reid, Deputy Director, Innovative Devices at the MHRA
  • Josh Crosley, Design for Life Co-Lead from DHSC
  • Anastasia Chalkidou, Programme Director for Healthtech Guidance Delivery at NICE
  • Heather Hobson from the Office for Life Sciences
  • Nata Zaman, Deputy Director of Equipping New Hospital Programme at NHS England
  • Paul Gaffney, Director of Tendo
  • Daniel Laing, Senior Account Director for Tendo
  • Chris Corkan, Region Director & Affiliate Partnerships at MakeUK
  • Chris Taylor, Sustainability & Social Value Focus Group Convenor at AXREM
  • Matthew D’Arcy from Highland Marketing

The Future of MedTech conference has received positive feedback from attendees.

Shona Macdonald, Director of Market Access & Reimbursement, UKI, at Convatec, commented: “The BHTA and AXREM conference proved to be a highly relevant and extremely interesting agenda. It provided me with an invaluable opportunity for networking and engagement with stakeholders and peers.

“I was particularly encouraged to hear that collaboration with industry through the NHS transformative changes is both invited and welcomed by the system.”

David Dawson, Market Access Director, UK/Ireland for BD, said: “I found the BHTA conference both interesting and informative. The varied subject matter and speakers provided a good mix of important issues. I especially enjoyed the afternoon presentations and panel discussion.”

Diane Hargrove, Sales Director at BES Healthcare, stated: “I thought the quality of the speakers was excellent, and it was refreshing to hear that there seemed to be an understanding of some of the real challenges that face industry in bringing new innovative technologies through to the healthcare market.”

Richard Holland-Oakes, Co-Founder and CEO of Recare, noted: “Certain parts of the day were very interesting with the NHS and social services and the government finally trying to work together. 

“I must say it appeared the presentation to be more hospital-related savings with the AXREM companies rather than the companies of BHTA and the products of which you support, NHS/community and the private sector and of which our products are bespoke to the individuals requirements, and of these products that are prescribed from the hospital environment for home use is a hard to manage and deliver a better service and savings without changing this structure that is in place at present. But it can be done!”