Statutory review of the Coronavirus Test Device Approvals (CTDA) process - ISS-G20 Laboratorium Repository

The requirements of the Coronavirus Test Device Approvals (CTDA) process are set out in the Medical Devices Regulations (MDR) 2002 and govern the validation of antigen and molecular coronavirus (COVID-19) detection tests. The process was introduced in July 2021 in response to an influx of poor quality tests coming onto the UK testing market at a time when availability of accurate diagnostic test results had the potential to be an important part of the COVID-19 response.

The CTDA requires antigen and molecular COVID-19 tests to undergo mandatory desktop review by the UK Health Security Agency (UKHSA) to assess their performance before being put into service or placed on the market. The Secretary of State committed to publishing a review of the CTDA.

This review evaluates the impact of the legislation, identifies any lessons learnt and discerns whether the policy has met its key objectives, as defined in the initial impact assessment. It forms the basis for subsequent work on the future of the legislation. It should also consider how the experience of introducing legislation during a pandemic to respond to a specific market failure has played out in practice. This will inform longer decisions about the future of the policy and the potential systems that may be required for other pathogens as part of infection risk management in future significant outbreaks or pandemics.

The government has conducted a review of the policy, making use of existing management information, internal data, and evidence from stakeholders. This was completed in line with the HM Treasury’s Magenta Book on best practice in designing an evaluation. This was to ensure good analytical practice was followed and created alongside the main report to inform and support the resulting conclusions and decisions.

This review sets out the context in which the legislation was introduced, including the course of the pandemic at the time and the availability of testing. It assesses the operational performance of the CTDA and uses that assessment to inform whether and to what extent the CTDA has met its original objectives. It also briefly considers the alternative models for diagnostic device validation.

Overall, it is clear that the CTDA has met its principal and overall objective of improving the quality of tests on the UK market and has successfully addressed the market failure that saw poor quality, inaccurate tests made available for sale. A large number of tests have now successfully passed through the process, indicating a robust market that gives consumers genuine choices.

Whilst the process for approving tests was initially slower than planned, the speed has increased significantly, and the quality of applications has improved as the CTDA regime has matured. The approved register is publicly available on GOV.UK and allows consumers to verify that the test they are purchasing has been validated. However, it does not allow for meaningful comparison of test performance between those devices that meet the minimum standards, so its utility as a comparative tool is limited.

The conclusions in the review will be taken into account when considering CTDA’s future and the future of diagnostic policy more generally.

Entire content available on: https://www.gov.uk/government/publications/coronavirus-test-device-approvals-ctda-statutory-review-of-process/statutory-review-of-the-coronavirus-test-device-approvals-ctda-process