Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, which businesses are awaiting approval from the Medicines and Healthcare products Regulatory Agency to (a) supply lateral flow tests to the NHS and (b) for the use of those tests in the UK.

The Medicines and Healthcare products Regulatory Agency (MHRA) does not approve COVID-19 testing devices. Tests for professional use are subject to self-assessment by the manufacturer before they may be placed on the market. Self-test devices are required to be assessed for conformity to the regulations by an Approved or Notified Body. In addition, tests must also meet the COVID Testing Devices Authorisation requirements.

In exceptional circumstances, the MHRA can issue an Exceptional Use Authorisation (EUA). The MHRA publishes the names of tests and other medical devices which have been granted an EUA online. The MHRA does not currently have any outstanding decisions for EUAs.