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January 31, 2022updated 21 Mar 2022 9:03am

New regulations due to Brexit may limit medical devices from entering the UK

Difficulties with marketing medical devices in the UK and EU may deter manufacturers from launching new products in the UK.

By GlobalData Healthcare

Geopolitical events such as Brexit can lead to profound effects on local, regional and global healthcare markets. Brexit, the UK’s withdrawal from the European Union (EU), prompted a period of uncertainty in the country’s healthcare market during the transitional years, starting with the initial vote to leave in 2016 and continuing to the present day. There is speculation over potential price increases in medical and healthcare supplies and disruptions in the supply chain. Delays can also occur due to the shortage of professional assessment as larger providers have pulled out of the market, leaving three approved bodies for UK medical devices.

The approval and marketing processes for new medical devices are more costly and time-consuming as manufacturers need to follow both EU and UK regulators. All manufacturers will need to register with the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), submit reports to the agency and receive a UK Conformity Assessed (UKCA) mark. In addition, new EU regulations such as the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) have delayed many companies as there are increased costs and time associated with the approval processes. As a result, with the additional hurdles associated with marketing medical devices in the UK and EU, manufacturers may be deterred from launching new products in the UK.

In a GlobalData poll of 218 participants, 50% agreed that Brexit will disrupt the UK’s ability to acquire the latest and safest medical devices. The new EU regulations, MDR and IVDR, have a higher degree of safety because of the EU’s increased standards on clinical data needed to market a new device. Since these new regulations are scheduled to take effect next year, GlobalData predicts that small-medium enterprises, especially from outside the UK and EU, will exploit opportunities to release and market cheaper medical devices that conform to the less-stringent old standards. This will lead to the release of devices that conform to different safety standards, which will lead to different price points. The increased safety standards in MDR-approved devices will win market share, which will affect the UK’s ability to gain the safest medical devices until they instil stricter safety regulations.

According to GlobalData’s thematic research report Brexit Impact on Medical Devices, Brexit holds a lot of uncertainty for the UK’s medical devices market. Despite Brexit, however, the UK’s in-vitro diagnostics segment accounted for 15% of total revenue in 2020. GlobalData projects that the UK medical devices industry is set to reach $19.8bn by 2030, as the UK is a popular location for clinical trials and home to the headquarters of 1,800 medical device companies. Although there is immediate uncertainty of Brexit’s impact on the UK medical devices sector, GlobalData expects the market to continue to grow as manufacturers adjust to the new UK and EU regulations.

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