Freedom of Information request on the approved manufacturers for the COVID-19 antigen lateral flow tests (FOI 21/999)
Published 25 February 2022
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-27-september-2021/freedom-of-information-request-on-the-approved-manufacturers-for-the-covid-19-antigen-lateral-flow-tests-foi-21999
28th September 2021
FOI 21/999
Dear
Thank you for your information request, dated 31 August 2021, where you asked for ‘a list of manufacturers and contact details for any medical devices approved by the MHRA for COVID-19 antigen lateral flow testing‘.
I am pleased to provide you with some of the information requested, see below.
MHRA does not approve medical devices. Medical devices placed on the UK market must conform to the requirements of the directive. This requires that devices perform safely while achieving the purpose intended by the medical device manufacturer.
MHRA has issued two derogations (Exceptional use authorisations, allowing use of non UKCA or CE marked devices) for lateral flow antigen tests for use in a self-testing scenario.
DHSC/NHS Test and Trace (Repurposed Innova/Biotime Test Kit) and Orient Gene have Exceptional Use Authorisations for self-test Lateral Flow test kits. You can find more information regarding these on our website.
Unfortunately, contact information of the manufacturers is exempt from release under section: Section 21 – Information accessible by other means: the information you have requested is already in the public domain. The Act’s section 21 exemption states that there is no right of access to information via FOI if it is reasonably available to the applicant by another route.
The Freedom of Information Act only entitles you access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.
If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.
If you have a query about the information provided, please reply to this email.
Yours sincerely,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000