Freedom of Information request on electronic copies of the delcaration of conformity for use for X-ray image interpretive software (FOI 22/612)
Published 27 March 2023
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FOI 22/612
11th May 2022
Dear
Thank you for your information request, dated 11 April 2022, where you asked for electronic copies of the Declaration of Conformity, Intended Use and/or Instructions for Use for X-ray image interpretive software commercially known as ‘red dot’ manufactured and registered by behold.ai (MHRA Reference Number 19796), as well confirmation of the device risk classification.
Unfortunately, the Declaration of Conformity is exempt from release under section 43 of the Freedom of Information Act 2000.
We do hold the instructions for use which includes an intended purpose statement for the product but it is exempt from release under section 41 of the Freedom of Information Act 2000. We advise you to contact the manufacturer directly for up to date copies of this information as well as information on the device risk classification.
With regard to the device registration, please note that the MHRA Public Access Database for Medical Device Registration lists all the devices registered with MHRA by GMDN term.
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 with regards to your request, you can ask for the decision to be reviewed. The review would be carried out by a senior member of the Agency who was not involved with the original decision.
After that, if you remain dissatisfied, you may write to the Information Commissioner at;
The Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.
Yours sincerely
MHRA Customer Experience Centre