Freedom of Information request on ethylene oxide (FOI 21/814)
Published 29 December 2021
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23rd July 2021
FOI 21/814
Dear
Thank you for your information request, dated 14 July 2021, where you asked for information on 3rd party companies and their processes in respect of residual EO levels.
I am pleased to provide you with the information requested, see below.
Please refer to the following which should answer part of your questions : https://www.gov.uk/government/publications/approved-bodies-for-medical-devices
The bodies are subject to close scrutiny by MHRA to ensure that they are competent to carry out relevant tasks such as this.
A similar process exists in Europe and the following is a list of bodies which can carry out this task : https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13
The UK and EU bodies review the relevant test reports demonstrating that the residual EO levels on medical devices are below the specified allowable limit.
The Freedom of Information Act only entitles you to 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 have a query about the information provided, please reply to this email.
Yours sincerely,
MHRA Customer Service Centre