Region/Countries: Europe, United Kingdom Industry: Biosciences / Medical Devices Date: September 2020

Why this is important to Wisconsin businesses: Wisconsin exporters of medical devices and technologies are in a better position relative to European companies thanks to Brexit.

The UK government acknowledges that its National Health Service (NHS) lags behind in adopting new technologies and is committed to addressing the situation to ensure patients receive the full benefits of medical advancements. The best sales prospects for U.S. manufactured medical devices include assistive technologies, electronic monitoring equipment, home care and cancer care technologies, rehabilitation equipment and diagnostics.

The UK has a flourishing medical device industry—the third-largest in Europe and sixth in the world, valued at $16.8 billion in 2019. The sector comprises more than 2,000 companies, and directly employs about 80,000 and indirectly an additional 250,000. Over 80% of firms are small and midsize enterprises, but a large number of leading U.S. manufacturers have also based head offices or subsidiaries here. The sector is spread across the country, with main clusters in the West Midlands and the east and southeast of England. The strength of UK manufacturers lies in orthopedics, imaging, diagnostics and cardiovascular devices.

The UK spends $9.5 billion on medical devices annually. The EU is its biggest trading partner, with around £2 billion worth of goods exported into Europe each year and £3.3 billion in European medical products imported into the country. The NHS is the biggest consumer of medical devices, accounting for 80% of procurement, with the remainder by hubs and trust procurement teams.

The private sector focuses mainly on secondary and tertiary/elective care not covered by the NHS, e.g., cosmetic surgery and specialist dental care. Acute private hospitals are dominated by major hospital groups such as HCA Healthcare, Circle Health and BMI Healthcare. Although this segment is smaller, accessible opportunities also exist for companies to supply private hospital, residential and nursing facilities with equipment.

Full post-Brexit trade arrangements are currently under negotiation and remain uncertain. The UK has put in place a £25 million contract to establish a 12-month express freight service to maintain the supply of medical devices and pharmaceuticals into the country in the event of a no-deal Brexit. The British government hopes the contract will enable suppliers to ship small parcels into the UK on a 24-hour basis and transit larger packages within four days. This could ensure critical products reach patients even with border delays that cause customs and other logistical issues. Last September, the UK Medicines & Healthcare Regulatory Agency published initial details of how non-UK manufacturers could place their new devices on the UK market by engaging with the recently created UK responsible person, which replaces the traditional EU authorized representative. Companies also selling into the EU will still need an EU-based authorized representative. Existing product registrations will remain valid for the time being, but new regulations are expected to be implemented in phases, and may require separate conformity checks for the EU and the UK.