Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 6 January 2022 to Question 98916 on Coronavirus: Screening, which body is responsible for the accreditation of businesses to supply covid-19 lateral flow tests to the NHS.

There is no accreditation process which applies to the businesses supplying COVID-9 lateral flow device (LFD) tests to the National Health Service. However, COVID-19 tests must have either a CE-mark or UKCA mark and either approved under the Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 or listed on one of the temporary protocols. Where the UK Health Security Agency (UKHSA) or the devolved administrations procure LFD tests on behalf of the NHS, Coronavirus Test Device Approval is not required. However, the UKHSA evaluates these tests in a laboratory to ensure they display performance characteristics desirable for population testing. This evaluation is performed in advance of any procurement.