Global competition, domestic regulatory divergence, and National Health Service (NHS) procurement efficiencies are contributing to a complex innovation picture for medical device manufacturers looking to bring new products to market in the UK. While the challenges are increasing, there are still several opportunities for companies, especially if the right pathways are taken and strategic outsourcing is explored.

Average approval timelines for UKCA/CE submissions currently range from 24 to 30 months. Compare this to just 12 to 18 months under the FDA’s Breakthrough pathway in the U.S., or under a year in Singapore and South Korea, and you quickly begin to understand why the UK medtech scene risks falling behind.

Dig a bit deeper and the data is stark. 62% of domestic OEMs cite regulatory staffing shortages as their biggest challenge, while half have delayed product launches due to regulatory or NHS procurement hurdles.

Many face dual submission burdens, consuming up to 30% of regulatory capacity completely unnecessarily.

Even after regulatory approval, NHS adoption remains a bottleneck. Procurement processes are often slow, opaque, and misaligned with innovation timelines. The lack of real-world evidence (RWE) and economic value documentation further delays uptake.

“When you think of innovation and design excellence in medical device manufacturing, the UK is often the first country you think of,” explained Ian Goodacre, who has headed up the technical team at medical device outsourcing specialist Europlaz for almost a decade. “Our engineers and innovators are renowned for their inspiration and their ability to bring solutions to market that can help change the way conditions are treated and, ultimately, how lives are saved.”

He continued: “Despite our glowing reputation, UK original equipment manufacturers (OEMs) find themselves in the crosswinds of a complex landscape that is both opportunity-rich, yet structurally constrained. Global competition, domestic regulatory divergence and NHS procurement inefficiencies are converging to paint a volatile picture—especially compared with more favorable market conditions enjoyed across the EU and the U.S.”

What does this mean for the UK; where does it need to go?

While the data highlights stark disparities between the UK and global peers, the real value lies in understanding what these benchmarks mean for OEM competitiveness and the structural changes required to close a widening gap.

Skills, like in many manufacturing sectors, is a challenge for many. A lot of companies lack sufficient in-house regulatory expertise to help push new innovations forward and achieve compliance.

This means some of them use external specialists and end up joining a queue for support in what is already a saturated marketplace. It also takes an element of control away from the OEM and this can cause significant delays.

“Brexit and the transition to MDR/IVDS have increased demand for professionals that are familiar with both UKCA and CE marking,” pointed out a frustrated Goodacre. “There is a real shortage of talent in this arena and this, combined with the preparation and submission of regulatory dossiers, causes bottlenecks in approval times.”

“Staff also have to contend with dual submission burdens,” he went on. “Although it’s not currently mandatory, many OEMs prepare for both, in order to future-proof access. This can consume between 20 to 30% of regulatory capacity unnecessarily and adds complexity to submission workflows and slows down the overall process.”

Even after regulatory approval, UK companies face hurdles in getting products adopted by the NHS. Procurement processes are often unclear, slow, or misaligned with innovation timelines and then you have lack of real-word evidence value documentation that further delays uptake.

By the contrary, the U.S. and APAC regions are stripping away regulatory friction. The FDA’s Breakthrough Device Program and streamlined pathways in Singapore and South Korea are attracting innovators and investors who are turning their back on the slower and less competitive UK market.

Now comes the opportunity

Despite these difficult trading and regulatory barriers—a lot of them out of the control of OEMs—it’s not all doom and gloom.

Goodacre, who works with more than 25 different manufacturers, believes that in order to close the gap and remain competitive against international peers, UK firms must start by streamlining documentation by using modular technical files that are adaptable across different jurisdictions.

They should look to embed compliance (ISO 13485, MRD, UKCA) early in product design to avoid costly rework and delays, whilst aligning with NHS priorities by building real-world evidence can be crucial.

“The NICE Early Value Assessment (EVA) program is a really promising development aimed at addressing some of these bottlenecks,” added Goodacre. “In theory, it should provide a structured pathway for technologies that meet national unmet needs to gain conditional NHS recommendations while further evidence is generated. This could be a real game-changer.”

“EVA offers rapid assessments for medical technologies, especially diagnostics, devices and digital tools,” continued Goodacre. “It also provides early value signals for promising innovations and conditional recommendations published as Health Technology Evaluations (HTEs). We are led to believe there will be support available for evidence generation so that full adoption, after the early positive signs, can be completed. It’s a welcome change of intent, we just need to see how it works in reality.”

Leveraging strategic outsourcing to mitigate staff shortages and accelerate throughput is the fourth and final point of the action plan and the area where Europlaz has the most experience.

The Southminster-based company recently completed a £4m investment drive to create a world class production facility capable of injection molding, assembly, product validation, and access to modern cleanrooms—all certified to ISO Class 7 for the manufacture of Class I, Class II and Class III medical devices.

It is already working with over 25 medtech innovators and OEMs, providing outsourced manufacturing capabilities that allow firms to scale up quickly and accelerate time to market.

Goodacre picked up the story: “Long-term outsourcing and supplier partnership are no longer just cost-saving tactics—they are essential tools for building resilience and reducing delays as the medical sectors moves into 2026. When OEMs consolidate and deepen collaborations with manufacturing partners, they can unlock several strategic advantages, including reduced fragmentation across the product lifecycle (design transfer, assembly and sterilisation for example), streamlined validation and documentation and mitigation against inflationary pressures and logistical shocks.”

He concluded: “The next five years offer both risk and opportunity. UK manufacturers who embrace strategic outsourcing, modular documentation and compliance-by-design will thrive regardless of external reforms. Contract manufacturers aren’t just vendors—we are growth enablers. By embedding resilience, UK OEMs can secure lasting competitive advantage in a shifting global landscape.”