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Brexit Impact on Medical Devices – Thematic Research

Geopolitical events can often have profound impacts on local, regional, and global healthcare markets. Many major medical device firms operate across many global regions instead of remaining local. As such, political, social, and geographic events can place unexpected strain on players in the healthcare space.

When the UK underwent a referendum to leave the EU, it triggered a period of political turmoil. Brexit came with a lot of uncertainty regarding how the country’s healthcare market would behave over the following years. Everything from expert personnel to supply chains was expected to be impacted, and this impact is still far from clear. Providers are facing uncertainty moving forward regarding medical supply chain disruptions as well as potential price increases, which could put undue pressure on the healthcare system overall. Recruitment of international experts across the healthcare spectrum is also potentially impacted, which could lead to a lack of surgical and medical expertise in the country.

There also remains uncertainty regarding the approval of medicines and medical devices, including software and technology. Regulatory hurdles could disrupt the approval of existing and new devices and technology. Coupled with financial stress on the public healthcare system of the UK, there is serious potential for lagging uptake of technology.

What are the main trends shaping the Brexit theme over the next 12 to 24 months?

From a COVID-19 testing perspective, the UK has been continually under pressure. Technological developments have eased the burden on testing laboratories by extending testing into the point of need setting. However, laboratories have been rapidly overwhelmed by demands for tests, increasing result reporting delays. Delayed test results have impacted track and trace efforts (COVID-19 case tracing) and likely have contributed to exacerbating the crisis. While the establishment of ‘mega labs’ such as Lighthouse Laboratories helped, increasing quality control issues due to a lack of trained staff devalued their impact. The government turned to population-level testing to ease restrictions and the demand for increased point-of-care tests, such as antigen tests.

Medical device regulation is an area where the UK had scope to make different policy choices than the EU. But the MHRA recognized that the situation post-Brexit left the UK out of step with international best practice and technological developments. It published a consultation focusing on patient safety and innovation, recognizing that gaining and maintaining competitiveness in a global market will be best supported by alignment with internationally recognized best practice and standards, including new EU regulations.

COVID-19 demonstrated the importance of resilient international supply chains for medicines and medical goods, such as personal protective equipment (PPE). Normal market dynamics ceased to exist, and typical NHS procurement procedures were affected. It was essential that the government adapted its approach to sourcing critical equipment and, as a result, protocols for the rapid procurement of critical equipment and PPE were implemented.

Strict controls on migration may make gaps in the health and social care workforce harder to fill. The NHS is the biggest employer in the UK, with over 1.3 million staff. Staff shortages in the UK’s healthcare sector are an ongoing problem, and Brexit may worsen the issue.

What are the insights of the Brexit impact on medical devices analysis?

The UK medical device industry

The UK medical device market is the third largest in Europe, behind Germany and France. Domestic device manufacturing is characterized by a large number of small-scale medical device companies alongside a few global manufacturers with a significant presence in the market. The in vitro diagnostics (IVD) segment is the largest in the UK medical devices sector, in 2020. This sector was mainly driven by the COVID-19 testing market. The UK is also an attractive location for clinical trials, being among the top five global countries for clinical trials locations.

Post-Brexit regulatory implications

On September 16, 2021, the MHRA published its open consultation on the future regulation of medical devices in the UK. The proposals cover the full medical device lifecycle from pre-market approval, through to supply and post-market monitoring, and includes significant changes in scope and classification, placing more stringent requirements on manufacturers and tightening vigilance measures.

The UK’s ability to acquire the safest medical devices might be disrupted

The MHRA consultation has safety as the standard. However, the results from the consultation are not coming into effect until 2023. Until then, small-medium enterprises (SMEs), particularly from outside of the UK and EU, are likely to exploit opportunities to market cheaper medical devices conforming to old standards. Additionally, devices conforming to different standards could be placed on the UK market.

Manufacturers could be deterred from placing products in the UK market

Approval and marketing of the products are expected to become complex and lengthier as manufacturers will need to comply with the regulations of both the EU and the UK. Because of this additional authorization process required to reach the UK market, companies could be deterred from selling their products in the region. Furthermore, medical device market leaders are expected to follow EU practice, since they are already heavily invested in the highly regulated market.

Impact on pipeline products

Many medical devices may gain an accelerated path to market by adopting current UK regulatory requirements rather than EU MDR requirements. Conversely, as these are devices in the latest stage of development, they are most at risk from a new UK regulatory regime being introduced before July 2023 when CE certificates lose recognition by the UK authorities.

Impact on clinical trials

For trials being conducted in the UK, the MHRA will continue to accept the legal representative or sponsor located in the UK or a country on the approved list of EU and European Economic Area (EEA) countries. For sponsors in the rest of the world with a UK-based legal representative, if the trial includes EU or EEA sites, the representation must be transferred to the EU or EEA. The end of the transition period has led to changes in the way clinical trials located in the UK or involving UK-headquartered companies are registered and conducted.

Market report scope

UK medical device market size (Year – 2020) $15 Billion
Growth rate (2021-2030) >3%
Base year for estimation 2020

Reasons to Buy

  • Develop and design your corporate strategies post-Brexit through an in-house expert analysis of the key factors to impact the post-Brexit UK medical device industry.
  • Stay up to date on the industry’s changing sentiment towards Brexit.
  • Identify emerging industry trends post-Brexit to gain a competitive advantage.

Table of Contents

Executive Summary

Thematic Briefing

Trends

Industry Analysis

Glossary

Further Reading

Our Thematic Research Methodology

Frequently Asked Questions

The UK medical device market is the third largest in Europe, behind Germany and France. It was valued at more than $15 billion in 2020.

The UK medical device market will grow at a CAGR of more than 3% during the forecast period of 2021-2030.

The in vitro diagnostics (IVD) segment is the largest in the UK medical devices sector, in 2020.

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