Question to the Department of Health and Social Care:

To ask Her Majesty's Government what assessment they have made of the impact of the new COVID-19 test device validation approval process (CTDA) on COVID-19 multiplex tests for influenza and other diseases; and, further to clinical demand, what plans they have to change these processes to speed up approvals.

An assessment regarding the impact of the COVID-19 Test Device Validation Approval process (CTDA) on multiplex tests is ongoing. A public consultation ended on 30 September 2021 and a response will be published later this year. As the approval process safeguards consumers and has been determined by scientists, we have no current plans to amend it for multiplex tests.

The Department plans to recruit more full-time scientific advisors to meet clinical demand and accelerate CTDA approvals. We anticipate the recruitment campaigns will be concluded shortly. However, the speed of the approval process is also dependent on manufacturers submitting the correct data at the application stage.