BMJ investigation prompts tougher Medicines and Healthcare products Regulatory Agency (MHRA) regulation of self-test kits The UK self-testing market has grown significantly and is projected to generate £660m in revenue by 2030. Now, a range of tests is available directly to consumers without medical involvement. In light of this, Professor Jon Deeks, Dr Clare Davenport and their team from the University of Birmingham conducted research 98 on 30 types of direct-to- consumer kits to evaluate their reliability. Publishing their findings in The BMJ, 99 they found 60% of these tests to be high risk, with concerns about testing equipment, instructions or interpretation of the results. Building on this research, The BMJ Investigations Unit revealed many self-testing kits available on the UK high street to be inaccurate and unfit for purpose, questioned regulatory bodies and urged them to implement tighter regulation to protect individuals from misinformation and reduce the burden on healthcare systems. 100 In May 2026, the MHRA published proposed changes to the regulatory requirements for medical devices and in vitro diagnostic devices entering the UK market. The proposals would make it illegal to mislead patients about a test’s purpose, safety or performance. 101 The British In Vitro Diagnostics Association, which represents 97% of the national industry manufacturers and distributors for medical diagnostic tests responded to this research on LinkedIn saying: "BIVDA strongly supports the NIHR Birmingham Biomedical Research Centre diagnostic team in helping to drive change in medical device law."
Through our investigative reporting and collaboration with researchers, we’ve helped push for changes in safety policy. The MHRA’s new draft rules are designed to make clinical research more transparent and help rebuild trust in consumer healthcare products. Now there is an opportunity for consumers and consumer organisations to challenge misleading clinical claims. Whilst manufacturers will still not legally need to share reports of their
clinical studies, they will be challenged if they do not.” Jon Deeks, Professor of biostatistics, University of Birmingham, UK
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