FOI release

Freedom of Information request on traces of ethylene oxide in medical devices after sterilisation (FOI 22/806)

Published 21 December 2023

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FOI 22/806

19th July 2022

Dear

Thank you of your email dated 28th June 2022.

The information you have requested is exempt under Section 21 of the FOI Act (information accessible by other means). You may access this using the link below:

https://www.gov.uk/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/for-patients-the-public-and-professional-users-a-guide-to-covid-19-tests-and-testing-kits

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.

I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division

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