The UK has the third largest medical device market in Europe, and overall sixth largest market in medical devices worldwide. The UK medical device market was valued to be over €17bn in 2020, coming third after Germany at €41bn and France at €31bn. In addition to Germany, France, Italy, and Spain, the UK is amongst the top five European countries for in vitro diagnostics (IVD). Since Europe holds 27.6% of the worlds medical device market, second to the US and valued overall at €140bn, this strengthens the UKs position as a strong emerging leader in the global medical device industry.
Domestic medical device manufacturing in the UK is characterised predominantly by small and medium sized enterprises (SMEs), which account for around 84% of the market, in addition to some larger global manufacturers which exhibit a significant presence in the market. Many large US companies, such as AbbVie, operate subsidiaries in the UK, which ultimately increases the size and scale of this industry in the UK. The UK market is largely driven by both the development and sales of medical devices targeting diagnostic imaging, cardiology, and in vitro diagnostics; however, orthopaedics and ophthalmic targeted medical devices are emerging as strong players in the market.
The UK medical device market is primarily an import-driven industry, with over 80% of medical devices being approved and sold in the UK. This itself presents the UK medical device market as particularly appealing to companies not only looking to enter the UK market, but to use the UK as a gateway to access the wider global market. One of the most successful examples of these companies is Fukuda Denshi, a Japanese medical equipment developer and supplier which opened its UK headquarters in 1996. Fukuda Denshi has since established itself as one of the largest medical equipment suppliers across the globe, with significant presence in over 80 UK National Health Service (NHS) public medical trusts and private hospitals, in addition to the generation of over £750m in global sales in over 75 countries worldwide.
The NHS is the primary medical device buyer in the UK, which can present additional challenges for companies to navigate market access due to the unique regulatory requirements. Prior to the UK exiting the EU in January 2020, medical devices entering the UK were subject to European regulations. This involved European CE marking, which will continue to be recognised in the UK until the 30th June 2023 only. Additionally, EU medical device regulations which were previously approved prior to Brexit will continue to be valid for the UK up until 30th June 2023. In addition, all medical devices entering the UK market have to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA), in addition to obtaining UKCA marking, which came into effect on 1st January 2021.