Coronavirus: Screening

(asked on 10th January 2022) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether covid-19 lateral flow test products that are made in the UK for use in the UK are subject to (a) testing or (b) checking requirements that are (i) different or (ii) in addition to those applied to covid-19 lateral flow test products manufactured in the Far East for use in the UK.


Answered by
Maggie Throup Portrait
Maggie Throup
This question was answered on 26th January 2022

All COVID-19 lateral flow test devices and their manufacturers are subject to the Medical Device Regulations 2002 and COVID Testing Devices Authorisation requirements regardless of the origin of manufacture. There are no alternative or additional requirements for devices manufactured in the United Kingdom.

In exceptional circumstances, the Medicines and Healthcare products Regulatory Agency (MHRA) can issue an Exceptional Use Authorisation (EUA). The MHRA publishes the names of tests and other medical devices which have been granted an EUA online. All manufacturers are subject to the same EUA assessment standards regardless of the location of the manufacturer.

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