Form

How to place a Coronavirus (COVID-19) test kit on the market

What manufacturers need to do

Documents

Form for manufacturers of professional use COVID-19 (SARS-CoV-2) test kits

This file may not be suitable for users of assistive technology. Request an accessible format.

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

If you are a manufacturer/supplier of CE marked professional use test kits, fill in this form and send it to Devices.Regulatory@mhra.gov.uk.

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.

Professional users

The regulatory check does not include a review of the test performance to ensure its suitability.

See also In vitro diagnostic medical devices: guidance on legislation

This is a fast-moving situation and this page will be continually updated.

Published 20 March 2020
Last updated 25 March 2020 + show all updates
  1. We have provided a new form and updated instructions as to where it should be sent.

  2. Changed the email addresses to send the form to: covidtesttriage@dhsc.gov.uk.

  3. First published.