If you use assistive technology (such as a screen reader) and need a
version of this document in a more accessible format, please email email@example.com.
Please tell us what format you need. It will help us if you say what assistive technology you use.
We will tell you if it can be placed on the market.
Some manufacturers are selling products for the diagnosis of COVID-19 (SARS-CoV-2) 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.
We are developing specifications for SARS-CoV-2 tests and will make these available as soon as possible.
The regulatory check does not include a review of the test performance to ensure its suitability.