PARLIAMENTARY WRITTEN QUESTION
Coronavirus: Screening (6 January 2021)

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an exceptional use authorisation to the Department, who have taken on the role of legal manufacturer, for lateral flow self-tests ‘to find’ COVID-19 positive cases in asymptomatic individuals. The Exceptional Use Authorisation (EUA) was issued on 22 December 2020, MHRA reference, DEU/012/2020/003. EUAs are published on GOV.UK and is updated regularly

Tests cannot be deployed until the legal manufacturer has accepted and addressed the conditions of the EUA and this has been agreed with MHRA. It is the responsibility of the organisation procuring and deploying medical devices including tests to satisfy themselves that the test will perform and intended and meets their requirements.