The Medicines and Healthcare Products Regulatory Agency (MHRA) is no longer the responsible body for applications to place coronavirus test kits on the market.
MHRA also cautions against the community setting focus of some manufacturers:
“Some manufacturers are selling products for the diagnosis of coronavirus (COVID-19) infection in community settings, such as pharmacies.
“The current view of Public Health England is that use of these products is not advised.
“We can confirm that there are no CE-marked tests for home use, and it is illegal to supply such products.
“This is a fast-moving situation and this page will be continually updated.”
Read more here.