Freedom of Information request on the PCR test kits and Ethylene Oxide (FOI 22/044)
Published 31 May 2022
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FOI 22/044
8th February 2022
Dear
Thank you for your information request, dated 5 January, where you asked for information relating to the use and functions of PCR tests, the components which make up the PCR test kits as well as information relating to Ethylene Oxide and personal health.
Unfortunately, the information is exempt from release under Section 21.
Section 21 – Information accessible by other means: the information you have requested is already in the public domain, and can be found at For patients, the public and professional users: a guide to COVID-19 tests and testing kits - GOV.UK (www.gov.uk). 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.
Please note that all collection swabs used to test for Covid-19 are regulated as medical devices and must meet the regulatory requirements of the UK Medical Devices Regulations 2002. For a medical device to be safe to use, it must have a valid CE, UKNI or UKCA mark. These marks are a declaration by the manufacturer that the test meets the required standards of safety and performance. If it is sterile it becomes a Class Is medical device and should undergo a Notified Body /UK Approved Body (independent 3rd party) assessment of the aspects of manufacture relating to the sterility of the device before a CEUKNI, UKCA mark can be placed on the medical device.
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