How to Launch a Medical Device in the UK

I've been involved in launching medical devices and diagnostics into the UK market multiple times now, and the pattern is always the same. A company builds something genuinely innovative — a diagnostic panel with exceptional sensitivity, a device that could change clinical workflows, an IVD that addresses a real unmet need. The science is solid. The development team is brilliant. And then the commercial strategy falls apart because nobody understood how the UK market actually works.

What follows is not a textbook overview. It's a practical guide based on what I've learned from launches that succeeded and launches that stalled — covering the regulatory landscape as it actually stands in 2026, the NHS market access reality, and the commercial strategy decisions that most companies get wrong.

The Regulatory Landscape in 2026: It's More Complicated Than You Think

Let's start with the elephant in the room. The UK regulatory framework for medical devices has been in a state of controlled chaos since Brexit, and if you're planning a UK launch, you need to understand the current situation — not the situation from a 2022 guidance document.

The MHRA is your regulator. That much hasn't changed. But the transition from CE marking to UKCA marking has been extended multiple times, and the current position is that CE marks from EU Notified Bodies will be recognised in the UK until June 2030 for most device classes. The government announced this extension because the UK simply doesn't have enough Notified Body capacity to handle the volume of conformity assessments that a hard cutover would require.

What this means in practice: if you already have a CE mark under the EU MDR, you can place your device on the GB market without UKCA marking until 2030. If you're a non-EU manufacturer entering the UK for the first time, you still need to register with the MHRA, appoint a UK Responsible Person, and ensure your conformity assessment meets MHRA requirements. Northern Ireland follows EU rules under the Windsor Framework, so you'll need CE marking for that market regardless.

The classification system follows EU MDR categories — Class I, IIa, IIb, and III — but with UK-specific post-market surveillance requirements that are becoming increasingly rigorous. The MHRA has been signalling a move towards more active market surveillance, with mandatory adverse event reporting timelines that are tighter than some companies are used to.

Here's the critical insight that most companies miss: regulatory strategy and commercial strategy are not sequential. They're parallel. The indication you seek, the claims you make on your IFU, the clinical evidence you generate — these are commercial decisions as much as they are regulatory ones. I've watched companies spend two years in development, achieve regulatory clearance, and then discover that their approved indication doesn't align with the NHS pathway that would actually generate adoption. By that point, it's too late to pivot without another 12-18 months of work.

Start your commercial planning the moment you finalise your intended use. Not after clearance. Not during the submission. Before.

NHS Market Access: Where Good Products Go to Wait

Getting regulatory clearance to sell in the UK is necessary. Getting NHS adoption is a completely different challenge — and it's the one that kills most launches.

The NHS is the biggest customer in UK healthcare, and it operates through a procurement and commissioning system that is unlike anything you'll encounter in the US, Germany, or Japan. Understanding this system isn't optional — it's the entire game.

NICE (National Institute for Health and Care Excellence) is the first name everyone knows, but most companies misunderstand what NICE actually does. For medical devices and diagnostics, NICE operates through several programmes: Medical Technologies Evaluation Programme (MTEP) for novel devices, Diagnostics Assessment Programme (DAP) for IVDs, and Health Technology Assessments for more complex evaluations. Not every device needs NICE approval — but if your product requires a change in clinical pathway or represents a significant budget impact, a NICE recommendation makes the difference between national adoption and individual trust-by-trust persuasion.

The NICE process takes 12-18 months on average. If you're not engaging with NICE early — ideally during clinical development, not after clearance — you're adding a year or more to your time-to-market.

Integrated Care Boards (ICBs) are the local commissioning bodies that replaced CCGs in 2022. They control budgets and make adoption decisions for their populations. Even with a NICE recommendation, you still need ICB-level engagement to drive local adoption. This is where many international companies struggle — they expect a single national decision, and instead face 42 separate conversations with 42 different commissioning priorities.

NHS Supply Chain handles procurement for many device and consumable categories. Getting listed on their framework agreements is critical for volume adoption, but the tender process has its own timelines and requirements that need to be planned for 6-12 months in advance.

Then there's the practical reality of NHS budgets. The NHS is under sustained financial pressure. Every new technology competes not just against clinical alternatives but against every other demand on a constrained budget. Your health economic case needs to be watertight — not "our device is clinically better," but "our device saves £X per patient per year, reduces bed days by Y, and can be implemented within existing workforce capacity." If you can't make a compelling budget impact argument, your adoption will be glacial regardless of the clinical evidence.

Building Your Clinical Evidence Package

UK decision-makers — whether at NICE, ICB, or trust level — are evidence snobs. This is not a criticism. It's the reality of a publicly funded healthcare system where every pound spent on your product is a pound not spent on something else. Your evidence package needs to answer three questions convincingly.

First: does it work better than what we already have? Comparative effectiveness against the current standard of care is non-negotiable. Showing that your device performs well in absolute terms is necessary but insufficient. You need head-to-head data, or at minimum, a robust indirect comparison. The NHS doesn't adopt innovation for innovation's sake — it adopts innovation that demonstrably improves outcomes relative to existing practice.

Second: is it worth the money? Health economic analysis in the UK typically centres on cost per QALY (quality-adjusted life year). For devices, you may also need to demonstrate budget impact — the net financial effect on the NHS over 1-5 years, accounting for device costs, consumables, training, workflow changes, and downstream savings. If your device costs more upfront but reduces hospital readmissions, you need to quantify that precisely. Vague claims about "improved efficiency" won't survive a NICE appraisal committee.

Third: can we actually implement this? This is the question that companies most often forget to answer. Clinical utility and cost-effectiveness are necessary but not sufficient. The NHS needs to know: does this require new staff training? Does it integrate with existing IT systems? Does it fit within current clinical pathways, or does it require pathway redesign? A brilliant device that requires three months of staff training and a workflow redesign will lose to a mediocre device that plugs straight into existing practice. Every time.

The smartest thing you can do is generate UK-specific evidence early. Real-world data from UK clinical settings, even from a small pilot, carries disproportionate weight with NHS decision-makers. It addresses the "will it work here?" question that imported clinical trial data from other markets cannot fully answer.

Positioning: Why Most Companies Get It Wrong

Here's where I get slightly preachy, because I've seen this mistake so many times.

Most medical device companies position their products the same way they wrote their technical file — by listing specifications. Sensitivity: 99.2%. Specificity: 98.7%. Turnaround time: 45 minutes. Throughput: 96 samples per run. These are important data points. They are not a commercial strategy.

The problem with feature-based positioning is that every competitor is doing the same thing. When every product leads with the same metrics, the buyer defaults to price. And in the NHS, where procurement teams are under intense pressure to reduce costs, competing on price is a race to the bottom that erodes your margins and devalues your innovation.

Effective positioning in the UK market requires understanding that different stakeholders care about fundamentally different things — and your messaging needs to address each of them:

Clinicians want to know: what clinical decision does this enable that I couldn't make before? Not what it measures, but what it changes. A gene panel with 99% sensitivity is a specification. A gene panel that identifies treatment-responsive patients who would otherwise receive ineffective therapy — that's a clinical narrative.

Lab managers want to know: will this integrate into my existing workflow without disrupting everything else? What's the hands-on time? What training does my team need? What's the failure rate?

Procurement wants to know: what's the total cost of ownership? Not just the device price, but consumables, maintenance, training, and the operational impact on throughput and staffing.

Trust management and ICB commissioners want to know: what's the strategic case? Does this align with national priorities? Does it reduce waiting times, improve patient flow, or address health inequalities?

Your positioning needs to work across all of these audiences simultaneously while telling a coherent story. That's harder than it sounds, and it's the reason I've built an entire service around it.

Channel Strategy and KOL Engagement

The UK medtech market is small enough that personal relationships matter enormously, and large enough that you can't rely on them exclusively. Your channel strategy needs to account for both.

For complex, high-value devices, a direct sales force is almost always necessary. NHS procurement processes are relationship-intensive, and the consultative selling required in a clinical environment can't be outsourced to a generic distribution partner. Your reps need to understand the science, the clinical workflow, and the procurement process. If they can't have a credible conversation with a consultant about clinical utility AND with a procurement manager about health economics, they're not ready.

For consumables and lower-complexity devices, distribution partners can provide rapid market coverage. But choose carefully — the major UK distributors have their own priorities, and your product will compete for attention within their portfolio. A distribution agreement is not a sales strategy.

KOL engagement in the UK works differently from the US. The NHS consultant community is smaller and more interconnected. A handful of influential clinicians at major teaching hospitals can make or break your adoption trajectory. Identify them early, involve them in your evidence generation, and give them a reason to champion your product. The most effective approach I've seen is to engage KOLs during the clinical evaluation phase — not as paid endorsers, but as genuine collaborators who have shaped the product and have professional ownership of its success.

The Launch is Not the Finish Line

I'll end with the mistake I see most often. Companies treat regulatory clearance and market launch as the culmination of years of work. They celebrate, they issue a press release, and then they wonder why adoption is slower than projected.

Launch is the beginning of the commercial work, not the end. Post-launch, you need to be tracking clinical adoption rates and identifying barriers in real time. You need post-market surveillance systems that aren't just regulatory compliance exercises but genuine feedback loops. You need to be collecting real-world evidence from early adopters that strengthens your case for wider NHS adoption. You need to be monitoring competitive response — because the moment your product gains traction, every competitor in the space will be adjusting their positioning.

The companies that succeed in the UK market are the ones that plan for a two-to-three year adoption curve, invest in post-launch evidence generation, and treat every NHS trust conversation as both a sales opportunity and a learning opportunity. The science got you here. The commercial strategy determines whether anyone actually uses it.

If you're planning a UK launch and want to avoid the expensive mistakes, let's talk strategy.