Freedom of Information request on the claim for TB has now been removed from the brochure and whether MHRA requested manufacturer to do so? (FOI 21/1337)
Published 31 May 2022
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FOI 21/1337
21st December 2021
Dear,
Thank you for your email and we greatly apologise for the delay in our response.
With regards to the questions you raised please find our responses below.
(i). From previous MHRA correspondence, MHRA stated that “The claim for TB has now been removed from the brochure:” Can I ask if MHRA requested the manufacturer to remove this claim and if so, what was the evidence base for making this request of the manufacturer?
The MHRA did not make this request of the manufacturer. The manufacturer decided to remove this item from the labelling as part of a marketing update. All changes to a devices packaging have to be approved by the manufacturers approved/notified body; this is an independent organisation that evaluates all aspects of the device and issues a UKCA/CE certificate upon successful completion of a conformity assessment. The MHRA has been assured that the approved body have agreed this change.
(ii). In your correspondence, you mention that the testing had applied US standards and not UK/EU standards, but that MHRA had accepted the data anyway. Can I confirm with you, that it is acceptable for MHRA to accept a claim, even though the data supporting such a claim are not based on UK standards?
It is not compulsory for manufacturers to adhere to specific standards for any type of medical device. All medical devices must adhere to the essential requirements detailed in the UK Medical Device Regulations 2002. Harmonised standards do exist which if met by the manufacturer will adequately demonstrate they meet the relevant applicable requirements of the Regulations. However, if a manufacturer can show that they have conducted testing equivalent to that detailed in the standard and thereby demonstrate the relevant essential requirements of the Regulations have been met, this is also acceptable.
(iii) Please can you kindly forward to me all the data which your device specialists and clinical specialists considered in making their determination that the wipes are effective against TB.
MHRA are unable to share this data with you as such information is subject to confidentiality requirements detailed in the Medicines and Medical Devices Act 2021. Such a request could be treated as a Freedom of Information request, however as it is information provided to MHRA in the course of carrying out our regulatory function, the information would be exempted under Section 44 of the Freedom of Information Act 2000.
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.
Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices
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 Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU