US, UK or EU? What to Consider When Choosing Which International Market to Enter

Global Medical Devices Market Overview

The global medical devices market value is projected to reach $799.67 billion by 2030, with a Compound Annual Growth Rate (CAGR) of 5.9%. It’s thus clear that stakes are high for manufacturers wanting to place innovative devices in new markets, as new opportunities for enhancing patient care are arising thanks to technological innovation.  

Advancements in AI and robotics and the continuous development and deployment of innovative devices are not only driving innovation but also pushing regulators to adapt their outlook and demands to ensure patient safety, device effectiveness and ethical standards are upheld throughout the product lifecycle. Unfortunately, in the interim, these changes may lead to possible confusion when it comes to regulatory compliance as the industry transitions to more consolidated models. 

This evolving landscape requires businesses to consider expanding into new medical device markets to have a complete understanding of complex standards, guidelines and national regulations. In addition to this meticulous planning, tried and tested quality management systems and effective risk assessment strategies are also critical. Choosing the right market on which to make their first moves can be a key step in determining the future success of a device. 

This article will briefly cover essential factors to consider when deciding whether to initially introduce their device in the US, UK, or EU medical device market. 

Focus on Innovation and the NHS: UK First

The smaller of the three markets considered in this article, the UK’s medical device market, remains an extremely attractive entry point, especially for innovative and specialised products. In February 2023, in fact, the previous UK Government published The Medical Technology Strategy plan, signalling that the country is open to embracing healthcare innovation, with a strong emphasis on innovative software devices, which have climbed the regulatory priority ladder, opening up the possibility of novel, swifter routes to market. Digital innovation is also one of the focuses of the 2019 NHS Long Term Plan, which outlines priorities and objectives for the next ten years. This appetite for embracing innovative and cutting-edge technology to reduce the burden on front line healthcare will remain as the UK continues to look to reform the NHS and ensure it is equipped for the future demands of the nation’s health. 

On the regulatory front, the shift to the new UK Medical Device Regulation (MDR) is well underway, and the pace at which new requirements are emerging may catch many medical device manufacturers off guard. To accommodate the diverse requirements of advancing cutting-edge technologies, the UK is also exploring the speedy recognition of approvals from other countries to expedite market access and has introduced the acceptance of CE marked devices on the Great Britain market, deadlines dependant on the type of device and the legislation that the CE mark applied against. The latest of these deadlines is 30 June 2030.

EU First: Changing Regulations and New Opportunities 

The regulatory approval journey necessary to place a device in the European Union, accounting for 24.5% of global medical devices sales, is definitely more complicated if compared with, the consolidated UK system still in use. The body of evidence that the manufacturer needs to prepare to launch a medical device on the EU market is in fact much more extensive and manufacturers are required to engage with a Notified Body (NB) to certify the device, evaluate their QMS, review their technical documentation and assess their clinical evidence.  

To make matters more complicated, recent capacity concerns with NBs have caused delays, impacting time-to-market and patient access to vital devices. However, the EU Commission is actively taking steps towards simplifying the transition to the EU MDR/IVDR and extending deadlines for the implementation of new regulations, easing the burden on products already certified under older regulations. 

FDA, 510(k) and Predicate Devices: US First

Despite the FDA’s reputation for being a stringent regulator, the US medical device market, with its 43.5% share of medical device sales globally and valued at USD 176.7 billion in 2020, presents intriguing opportunities for medical device manufacturers. 

While introducing a novel device without a corresponding “predicate” device may pose challenges, most medium-risk devices can undergo a relatively straightforward 510(k) registration process. This demonstrates the device’s safety and effectiveness compared to an equivalent legally marketed device, alleviating concerns. However, complications may arise in accessing information about the predicate, particularly if it’s manufactured by another company, limiting available data to the public domain and making critical technical details harder to obtain. 

However, the costs linked to regulatory approval in the US are generally lower than in the EU and UK, and specific response timelines are followed by the FDA. Successfully completing a 510(k) submission can also mean eliminating the need for a clinical investigation, speeding up time-to-market and reducing overall investment. 

An important consideration in relation to obtaining a US 510(k) clearance, is the opportunity to leverage the clearance by using it to enter other global market territories that consider the US as a reference market. Countries such as India, South Africa and Israel, to name a few, recognise clearances and approvals from other reference regulatory bodies, and a 510(k) clearance can open other opportunities for market entry.  

For medical device manufacturers contemplating their initial market entry there isn’t of course a single straightforward answer. However, fully grasping the merits and drawbacks of the existing regulatory systems in major markets can provide valuable context for the decision-making process.  

Nevertheless, embarking on this journey without the guidance and expertise of experienced professionals can entail unwarranted risks, especially within today’s dynamic regulatory environment. 

Enlisting the support of international regulatory specialists not only aids in navigating the intricacies of specific markets, efficiently managing the expectations of regulatory authorities, but also facilitates the identification of areas of overlap among the regulatory requirements of different regions. This, in turn, assists in structuring a well-informed and strategic market entry approach. 

Disclaimer. The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of Test Labs Limited. The content provided is for informational purposes only and is not intended to constitute legal or professional advice. Test Labs assumes no responsibility for any errors or omissions in the content of this article, nor for any actions taken in reliance thereon.