Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to Ministerial Statement HC WS324 made on 18 October 2021, whether his Department has plans for the continued supply and usage of tests on the Coronavirus Test Device Approvals (CTDA) exempt list after the 28 February 2022 deadline in the event the approval process is not completed on schedule.

There was no requirement for Coronavirus Test Device Approvals (CDTA) reviews to be completed by 28 February 2022. This date refers to a temporary protocol which applied from 1 November 2021 to 28 February 2022, which allowed tests to stay on the market pending their CTDA outcome.

A new protocol containing two lists took effect from 1 March 2022, one for three months for certain devices until 31 May 2022 and one for six months until 31 August 2022, which is available at the following link:

https://www.gov.uk/government/publications/covid-19-test-validation-approved-products/medical-devices-regulations-2002-protocols-effective-from-1-march-2022

The new protocol allows the continued supply and procurement of those tests, whilst their CTDA application is being considered.