Strengthening consumer confidence in COVID-19 detection devices

This article is co-authored by Natalie Man, Litigation Assistant, London.

A significant number of COVID-19 test products sold in the UK have failed to replicate their stated performance for their intended use and in real world use evaluation.

On 2 September 2021 the UK Department for Health and Social Care (DHSC) opened a public consultation, seeking responses from businesses in the UK and internationally that are involved in the manufacture, distribution and sale of COVID-19 tests on proposals to introduce further scrutiny on tests available on the UK market under the Medicines and Medical Devices Act 2021.

This regulation sets out procedures for antigen and molecular COVID-19 tests to undergo mandatory desktop review to assess their performance before being permitted for sale on the UK market.

Proposed changes

In addition to the CE marking standard which currently applies to all tests sold in the UK, anyone seeking to place a COVID-19 test on the UK market will need both a pre-market requirement (in the form of a desktop review) and laboratory validation.

The basis of the initiative from the DHSC to process COVID-19 test products through the two-stage validation process will aim to:

  • Remove further poorly performing tests from the UK market.
  • Improve quality standards in specific areas of test performance.
  • Ensure all tests that are available on the market are of sufficient quality and fit for purpose to protect the public health.
  • Encourage manufacturers and suppliers to develop and drive up the standards of other diagnostics tests in the private sector market for COVID-19 detection tests to supplement the testing led by the NHS Test and Trace.

The Association of British Healthcare Industries (ABHI) have expressed concerns over the current validation process and have been working on a new regulatory framework with the MHRA to ensure the tests accessible to the UK market meet the minimum performance specification and good quality supporting evidence. The ABHI’s view on the DHSC’s proposal is that it merely creates an additional regulatory hurdle and suggests that the existing framework can be improved to resolve all apprehensions concerning quality.


It will be important that this new process is rigorous in the long-term management of COVID-19. Retailers, distributors and manufacturers of tests will need to ensure that all tests for sale in the UK meet the relevant quality standards. Manufacturers should consider specific products in question to achieve the required standards as they set out details to allow key stakeholders to fully understand the characteristics a test must have to be successful for its intended use. Any attempts to sell unvalidated tests could give rise to sanctions as breach of product safety regulations.

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