FOI release

Freedom of Information request on lateral flow tests and COVID-19 (FOI 22/386)

Published 31 May 2022

FOI 22/386

15th February 2022

Dear

Thank you for your email dated 18 January, where you asked for information related to the Covid 19 test.

We are pleased to provide you the following information.

1) “I note that the Government’s response to the Consultation outcome Private coronavirus (COVID-19) testing validation July 2021 refers to the powers exercisable by the MHRA in the context (Part 11).”

If you are referring to the consultation linked above I would clarify that this does not relate to testing providers but manufacturers of Covid 19 tests. The consultation relates to the Coronavirus Test Device Approvals (CTDA) which requires manufacturers to submit an application to DHSC to demonstrate that their tests meet the minimum standards of the CTDA before they can be marketed in the UK. You can view which tests have passed the CTDA requirements on the Government website, there are two lists:

• COVID-19 test validation approved products: these tests have passed CTDA and can be marketed within the UK
• Medical Devices Regulations 2002: protocol: these tests are engaging with CTDA and have been given temporary approval to continue supply in the UK pending their application outcome.

If a test is not listed on the above two pages then it cannot be sold within the UK and this is the area MHRA are responsible for enforcing.

With regard to private Covid testing providers, MHRA’s role is specific to ensuring that the medical devices being used by the testing provider are compliant with the regulations. The accreditation of the labs is the responsibility of UKAS and any breaches of The Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020 are enforceable by local authorities and/or Trading Standards.

2) “The number of allegations brought to the MHRA against private Covid testing companies during the years 2020 and 2021”

The MHRA have received 26 allegations of breaches of Medical Device Regulations.

3) “Whether any inspections have been carried out of private testing facilities during the same period”

7 inspections were carried out on private testing providers.

4) “How many private testing providers the MHRA has taken action against in terms of exercising its compliance and enforcement powers disaggregated according to compliance, suspension, safety and information notices (and restriction notices where appropriate) under the Medicines and Medical Devices Act 2021 and the relevant applicable Regulations of 2002; 2005 and the Medicines Regulations of 2022, for the same years”

The MHRA have exercised its compliance powers on all 26 referrals received in order to achieve compliance with the Medical Device Regulations 2002. No legal notices have been issued on private testing providers

5) “Any appeals made against a decision (if any) of the MHRA by a testing company?”

No appeals have been made.

If you have a query about the information provided, please reply to this email.

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely

MHRA Customer Experience Centre