New regulations due to Brexit could limit the entry of medical devices into the UK


Geopolitical events such as Brexit can have profound effects on local, regional and global healthcare markets. Brexit, the United Kingdom’s withdrawal from the European Union (EU), caused a period of uncertainty in the country’s healthcare market during the transition years, beginning with the initial vote to leave in 2016 and continuing to the present day. There is speculation about potential price increases for medical and healthcare supplies and supply chain disruptions. Delays can also occur due to the lack of professional assessment, as major suppliers have pulled out of the market, leaving three Medical Device Approved Bodies in the UK.

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

In a GlobalData poll of 218 respondents, 50% agreed that Brexit would 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 due to increased EU standards on the clinical data needed to bring a new device to market. As these new regulations are expected to come into effect next year, GlobalData predicts that small and medium-sized businesses, particularly outside the UK and EU, will take advantage of the opportunities to launch and market cheaper medical devices. and compliant with older, less stringent standards. This will lead to the release of devices that comply with different security standards, which will lead to different price points. Increased safety standards for MDR-approved devices will gain market share, which will affect the UK’s ability to obtain the safest medical devices until they introduce stricter safety rules.

According to GlobalData’s topical research report, Brexit Impact on Medical Devices, Brexit holds many uncertainties for the UK medical device market. Despite Brexit, however, the in vitro diagnostics segment in the UK accounted for 15% of total revenue in 2020. GlobalData predicts that the UK medical device industry is expected to reach $19.8 billion by 2030 , as the UK is a popular location for clinical trials and is home to the headquarters of 1,800 medical device companies. Although there is immediate uncertainty about the impact of Brexit on the UK medical device industry, GlobalData expects the market to continue to grow as manufacturers adapt to new UK regulations. and European.

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