Best foot forward – Pros and cons of entering the UK market first

by | May 30, 2024 | IMed Consultancy, MDR, New Markets, UK

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Welcome back to our new blog series dedicated to International Market Entry!

IMed’s team will look at three major markets for medical devices- the EU, the UK and the USA- highlighting some key considerations relating to entering each of these geographies “first” to help manufacturers make informed decisions and successfully expand the global presence of their products.

In our previous blogs we covered the current global regulatory scenario and its opportunities and the US market.

This third of four instalments will focus on the UK medical devices market.

The UK medical device market

While a smaller market than the overall EU and US, the UK is significant player in the global medical device market. Not only are there fewer language barriers for US manufacturers and indeed for many other producers that have adopted English as the lingua franca of commerce, but the appeal of the NHS which presents a “one provider/one payer” model, at least in perception, is significant. The 4 yearly tender framework offers a lot of potential to manufacturers that hope to interface with one single buyer.

The UK’s Medical Technology Strategy

In addition to this, the UK is increasingly positioning itself as an ideal market for products that are novel and niche (in contrast with the EU where NBs are under pressure and not taking on new products, and with the US where routes to approval for innovative and high-risk products are more complex). As published in the first ever Medical Technology Strategy plan in February 2023: “MedTech is a vitally important industry for the UK economy, representing over half of all life sciences employment, with businesses situated across the UK and contributing billions of pounds to the economy. As a country we are known for world-leading scientific research and development capabilities, and the UK health and care system is globally recognised as a successful and trusted health system, making the UK a major player on the global healthcare stage.”[i]

The document confirms that: “We must encourage ambitious, innovative research…helping secure the position of the UK as a global science superpower. Moving forwards, we have the opportunity to make the UK an even more attractive market for businesses by improving access, shaping our own regulatory framework, leading in research and development, and maintaining a strong international market presence.” [ii] This is exciting breeding ground for innovation and for innovative new medical device manufacturers, and we see a particular focus on innovative software devices being high up the regulatory agenda – with the potential for new and quicker routes to market being proposed.

Transitioning to the new UK MDR: an overview

From a regulatory perspective, the transition to the new UK MDR is in full swing with deadlines to meet new requirements following on from each other faster than many medical device manufacturers realise. To accommodate the contrasting needs of driving revolutionary technologies, the UK is also considering accepting the approvals of other countries to speed up admissions.

Currently, however, the UK is still operating a more mature regulatory system than the EU MDR, where risk classes are generally lower, especially for AI and Software devices as well as certain IVD products. As a result this period of transition between the current UK regulations and the potential new UK regulatory system, is an ideal time to enter the market before the transition brings about more uncertainty and potential complexity.

Choosing the right market for your medical device

In this complex environment it is hardly surprising that medical device manufacturers with new devices, or that want to expand into new territories, are confused. Costs, timelines, shifting deadlines and potential extensions, these are all elements of uncertainty that make the decision regarding market entry, and particularly which market to enter first, highly complex.

There is of course no clear-cut answer for medical device manufacturers evaluating which market to enter first, but understanding the strengths and weaknesses of the regulatory systems currently active in these major markets can help frame the decision-making process.

Without a doubt, device maturity, therapeutic area and classification will drive the selection of the market most likely to yield success, but venturing forth without experienced guidance and advice means taking unnecessary risks in what is currently a changing and complex regulatory landscape.

The importance of relying on international regulatory experts

Securing the support of international regulatory experts will not only help navigate the complexities of specific markets, managing the expectations of their authorities efficiently and rapidly, but can help identify areas of overlap between the different geographies’ requirements to help structure longer term expansion strategies.

Read more about it on our white paper, available on our Resources page, or contact the team at IMed Consultancy for deeper insight into the UK, US and EU regulatory scenarios: hello@imedconsultancy.com.

[i] Medical Technology Strategy Plan, February 2023, https://www.gov.uk/government/publications/medical-technology-strategy/medical-technology-strategy

[ii] Medical Technology Strategy Plan, February 2023, https://www.gov.uk/government/publications/medical-technology-strategy/medical-technology-strategy

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