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GUIDANCE · UPDATED 9 APRIL 2024

The UK government's first-ever medtech strategy sets out four priorities — supply resilience, innovative markets, enabling infrastructure, and specific market focuses — that will shape NHS procurement policy, demand signals, and supplier requirements for medtech companies over the coming years.

Medical technology strategy · first published 3 February 2023

What it says, in plain English

This is the UK government's inaugural Medical Technology (medtech) Strategy, published in February 2023. It covers the full breadth of medical devices — from basic consumables and surgical equipment to diagnostics and digital health tools. The strategy does not itself change procurement rules overnight; instead it sets the direction of travel and commits to future implementation plans across four priority areas: supply resilience, innovative and dynamic markets, enabling infrastructure, and specific market focuses. Small medtech businesses — who make up over 85% of the 4,190 UK companies in the sector — will be directly affected as NHS England (NHSE) develops new procurement policy, demand-signalling processes, and resilience requirements flowing from this strategy. SMEs bidding for NHS contracts should treat this document as early warning of requirements and evaluation criteria that are likely to follow in the near term.

WHO THIS APPLIES TO

Who it binds
All public-sector buyers
Contract values
any value
Sectors
Medtech sector only: general medical devices, active implantable medical devices (AIMDs), in-vitro diagnostic devices (IVDs), and digital health/software tools that drive them directly.

THE ENKII VIEW

For SME medtech suppliers, the strategy contains both opportunity and risk. On the opportunity side, the commitment to clearer NHS demand signals — including potential volume commitments and purchasing-at-scale — could reduce the commercial risk of developing genuinely innovative products, which is exactly the kind of confidence smaller firms need before investing in R&D. The risk is that incoming procurement policy reforms around supply resilience, interoperability standards, and product evaluation frameworks could raise the bar for contract entry: firms relying on proprietary consumable lock-in or single-use models may face new requirements to demonstrate resilience or sustainability credentials. SMEs that get ahead of these shifts — documenting supply chain resilience, engaging with the emerging Innovative Devices Access Pathway (IDAP), and aligning their products with NHS sustainability goals — will be better placed when the implementation plans land.

What a small business should do about it

1. Read the four priority areas (supply resilience, innovative markets, enabling infrastructure, specific market focuses) and map your product and business model against each — identify where upcoming procurement policy changes are likely to affect your contracts or bids.

All SME medtech suppliers to the NHSThe strategy explicitly states it will form the basis of future implementation plans that will set out detailed requirements; firms that understand the direction of travel now can prepare before mandatory requirements land.

2. Begin documenting your supply resilience measures now — multi-source suppliers, stock buffers, alternative manufacturing arrangements — so you can demonstrate compliance when NHS procurement policy formalises resilience requirements.

SME suppliers using proprietary consumable models or single-source supply chainsThe document states DHSC will work with NHSE 'on the development of procurement policy to promote the proportionate application of requirements for resilience' and signals heightened requirements specifically for proprietary-model suppliers.

3. Monitor the development of the Innovative Devices Access Pathway (IDAP) and register your interest early — it is designed to get innovative devices to patients at the earliest safe opportunity and could significantly shorten your route to market.

SME medtech innovators seeking NHS adoptionThe strategy commits to converging activities 'around an end to end innovation pathway' and specifically names IDAP as the vehicle for this, making early engagement strategically valuable.

4. Engage with the demand-signalling process when it opens — respond to NHS consultations, clinical network requests, and national product leadership exercises to ensure your product category and innovation is reflected in NHS priorities.

SME medtech innovators and R&D-active businessesThe strategy commits to providing industry with 'a co-ordinated national signal on detailed priorities for innovation by product segment' and exploring volume commitments; firms that help shape these signals are better placed to benefit from them.

5. Assess whether your products could be redesigned or repositioned for multi-use or remanufacturing, and if so, develop a roadmap — even a preliminary one — that you can reference in bids to show alignment with NHS sustainability and resilience goals.

SME suppliers of single-use medtech productsThe strategy explicitly requires 'a reduction in single-use devices' and signals that procurement will incentivise 'multi-use and remanufactured solutions'; early movers will have a competitive advantage.

6. Prepare to submit product evaluation data in a standardised, real-world-evidence format: invest in collecting post-market clinical data from NHS use now, ahead of the new class-based evaluation framework being formalised.

All SME medtech suppliersThe strategy calls for a 'streamlined system of product evaluation' incorporating 'real-world evidence from product usage in specialist NHS test facilities'; firms with this evidence ready will move through the new process faster.

7. Explore regional innovation clusters and life sciences support schemes (e.g. Life Sciences Innovative Manufacturing Fund) to strengthen UK-based manufacturing capability, which the strategy signals will be a feature of future supply resilience assessments.

SME medtech businesses across the UK (outside South East/London/East of England)The strategy notes 59% of medtech employment is outside the South East/London/East cluster and commits to 'increasing UK medtech manufacturing capability and capacity' as a resilience priority.

The rules, anchored to the text

Every rule below quotes the official document verbatim.

The NHS spends an estimated £10 billion a year on medtech products. (NHS England, all medtech product types, current baseline figure)

the NHS alone spends an estimated £10 billion a year on medtech

SMEs make up over 85% of companies in the UK medtech sector and account for around 31% of medtech employment. (UK medtech industry, all company sizes)

A significant amount of medtech employment in the UK, around 31%, is in small and medium-sized enterprises (SMEs), which make up over 85% of the companies in the UK medtech sector

There are just under 2 million medtech products registered for use on the UK market, of which around 500,000 different product types are regularly used in the NHS. (UK medtech market, all product types)

Today MHRA have almost 2 million different products registered for use in the UK, of which we estimate that around 500,000 different product types are regularly used in the NHS

Over 60% of the total NHS carbon footprint sits within the supply chain, with 10% attributed directly to medical equipment. (NHS England, medtech supply chain, sustainability context)

Over 60% of the total NHS carbon footprint sits within the supply chain, with 10% attributed directly to medical equipment

The strategy's vision is built on three core objectives: right product (safe, clinically effective, innovative, sustainable), right price (value for money, outcomes-focused, whole-pathway cost), and right place (access, availability, adoption, resilience). (All NHS medtech procurement and policy, England-primary with UK-wide intent)

Our vision focusses on 3 central objectives: right product, right price, right place

Supply resilience requirements are to be developed through procurement policy reform, with DHSC working with NHSE on proportionate resilience requirements for suppliers. (Medtech suppliers to NHS, with focus on critical medical technologies; scope of requirements to be determined in future implementation plans)

we will work with NHSE on the development of procurement policy to promote the proportionate application of requirements for resilience, alongside an assessment of the potential for voluntary initiatives and regulatory enhancements that can facilitate a proactive approach to supply resilience

Where proprietary consumable models are used, suppliers will be expected to meet minimum supply resilience standards reflecting the risk to patient safety. (Medtech suppliers using proprietary consumable models, NHS contracts, timing subject to implementation plans)

Where there are clear safety benefits to proprietary models there is a need to establish a range of heightened resilience requirements for the suppliers of these systems that reflects the risk to patient lives and wellbeing presented in the event of a disruption

The NHS is to adopt clinically appropriate standardisation specifications to support interoperable systems, reducing single-supplier lock-in. (NHS procurement of medical devices and equipment, England-primary)

As far as possible, the health system should adopt clinically appropriate standardisation specifications to support interoperable systems

A new innovation classification framework will be developed to define a common language for innovation and to help prioritise transformative over merely incremental innovations in procurement and evaluation. (All medtech suppliers seeking NHS adoption, timing subject to implementation plans)

we must work collaboratively with our stakeholders to agree a meaningful way to classify innovation that should include a commonly agreed language and a way to determine the value of innovation in terms of impact, be this value for money, efficiency, or patient outcomes and experience

A streamlined, class-based product evaluation system is to be developed, incorporating real-world evidence from NHS test facilities, to replace the current fragmented multi-evaluation landscape. (All medtech suppliers, NHS product evaluation processes, timing subject to implementation plans)

health partners must work together with industry to develop a streamlined system of product evaluation that is regarded by both as the gold standard... incorporating real-world evidence from product usage in specialist NHS test facilities

The government commits to providing clearer, more granular demand signals to industry, including exploring volume commitments and purchasing-at-scale to reduce commercial risk for innovators. (Medtech innovators, NHS England procurement, timing subject to implementation plans)

exploring options for volume commitments or purchasing at scale to support industry confidence in bringing new innovations to market while securing the best value for the health and care system

The Innovative Devices Access Pathway (IDAP) is to be developed as a clear, scalable, end-to-end route to market for innovative devices. (Innovative medtech manufacturers seeking NHS adoption, England-primary)

This will support the development of the Innovative Devices Access Pathway (IDAP) which aims to enable manufacturers to provide their innovative devices to healthcare professionals and patients at the earliest, safe opportunity

The strategy requires a reduction in single-use devices in the NHS, with greater adoption of multi-use and remanufactured solutions to improve supply resilience and sustainability. (Medtech suppliers of single-use devices, NHS procurement, timing subject to implementation plans)

We must reduce the volume of single use devices used in the UK health and care system through the increased adoption of multi-use and remanufactured solutions, while maintaining quality and safety of patient care

In 2021 there were around 60 different programmes supporting innovative medtech technologies, representing over £1 billion of funding. (UK medtech innovation support landscape, all innovators)

In 2021, there were around 60 different programmes supporting innovative technologies, representing over £1 billion of funding

This is a high-level strategy document; detailed implementation plans setting out specific actions, timelines and requirements will be developed subsequently. (All stakeholders; specific supplier requirements will be set out in later implementation plans)

This strategy will form the basis of future implementation plans that will set out in detail how these priorities will be addressed

This briefing is enkii's interpretation of the official document — the official text always governs.

Official document on GOV.UK

Source document © Crown copyright, reused under the Open Government Licence v3.0 via the GOV.UK Content API. enkii tracks every Procurement Policy Note and briefs changes the day they land — see all briefings.