Question to the Department of Health and Social Care:

To ask Her Majesty's Government what plans are in place for the Medicines and Healthcare products Regulatory Agency to license rapid saliva-based COVID-19 test kits for public and home use.

A COVID-19 test may be placed on the market in the United Kingdom if it bears the CE mark. A CE mark is a logo that is placed on medical devices by the manufacturer to show they conform to the requirements in the regulations. It shows that the device is fit for its stated intended purpose and meets legislation relating to safety. The Medicines and Healthcare products Regulatory Agency (MHRA) has a range of investigatory and enforcement powers which we use to ensure the safety and performance of medical devices.

The MHRA is supporting the Department’s National Testing Programme and manufacturers seeking to bring new tests to market by publishing target product profiles or performance criteria for new tests, providing expert review of performance and research study protocols and offering regulatory flexibilities such as Exceptional Use Authorisations which allow promising, but as yet non-CE marked tests to be put into use where there is clear clinical need.