Freedom of Information request on Revolax and CE marking (FOI 21/1044)
Published 27 April 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-4-october-2021/freedom-of-information-request-on-revolax-and-ce-marking-foi-211044
5th October 2021
FOI 21/1044
Dear
Thank you for your information request, dated 7 September 2021, where you have explained that “Revolax used to have a CE mark which was withdrawn for some reason and now the product is being sold again with a ‘CE’ mark” and asked to “confirm to me that a copy of a valid CE certificate has been provided to yourselves.”
Currently no information is recorded on our public access databases for this manufacturer name. We would need manufacturer and specific account reference to investigate further.
If the information were available for public scrutiny then you could review the following MHRA webpage: Public Access Database for Medical Device Registration (mhra.gov.uk)
via MHRA webpage Register medical devices to place on the market - GOV.UK (www.gov.uk)
The information may be in the public domain therefore on this basis MHRA would be unable to provide further information as outlined in Section 21 of the Freedom of Information Act i.e. Information accessible by other means: the information you have requested is already in the public domain, and can be found at the website provided above. 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.
Finally, if it was found that there was an ongoing investigation, so as to not influence that investigation, we would be unable to provide information based upon section 30 (investigations) and section 43 (commercial interests) of the Freedom of Information Act.
Ultimately, it is best advised that you contact the manufacturer directly and/or notified body for them to verify.
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