Guidance

Guidance on coronavirus (COVID-19) tests and testing kits

Advice on the use of testing kits and applications to place them on the market.

Advice for manufacturers

MHRA is no longer accepting applications to place test kits on the market.

Send enquiries to covidtestingtriage@dhsc.gov.uk.

We are developing specifications for coronavirus (COVID-19) tests and will make these available as soon as possible.

Advice for members of the public and professional users

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.

MHRA guidance on coronavirus (COVID-19)

In vitro diagnostic medical devices: guidance on legislation

Published 2 April 2020