Freedom of Information request about the Streams app (FOI-21-471)
Published 28 June 2021
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Thank you for your information request, dated 22 April 2021, where you asked for ‘In relation to Google DeepMind, are you able to let me know when the Streams app was first given CE marking as a Class 1 Medical Device, and when MHRA was first notified of the intend to undertake a Clinical Investigation? ’
With regards to the Clinical Investigation, MHRA would not have been notified about any Clinical Investigations as these are not required for Class 1 medical devices to be CE marked.
Unfortunately, other information you have requested is exempt from release under section:
Section 21 – Information accessible by other means: the information you have requested is already in the public domain, and can be found at our Publicly Accessible Registration Database (PARD) 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.
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 will be carried out by a senior member of the Agency who was not involved with the original decision.
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