Freedom of Information request on the details and information for product Silvercloud (FOI 22/764)
Published 21 December 2023
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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-july-2022/freedom-of-information-request-on-the-details-and-information-for-product-silvercloud-foi-22764
FOI 22/764
4th July 2022
Dear
Thank you for your information request, dated 7th June 2022, where you asked for:
‘under the freedom of information act can you please provide me with all the details and information you hold about the Silvercloud product? Unfortunately, I couldn’t find anything about it on your website so I hope you can help me by answering my questions. Does the software qualify as a medical device? What is the intended use of the product and has the product got the MHRA approval? Any related documentation would be greatly appreciated, many thanks in advance.’
It is the manufacturer’s responsibility to define the intended purpose and determine whether their product qualifies as a medical device. If a product does qualify as a medical device, the manufacturer must ensure that it is compliant with the medical device regulations, and if the product is class IIa or above, it needs to be authorised by a UK Approved Body or EU Notified Body. The MHRA do not approve medical devices. However, manufacturers must inform the MHRA of:
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clinical investigations of non-CE / UKCA marked devices – MHRA guidance on notifying about a clinical investigation for a medical device
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CE / UKCA marked medical devices before they are placed on the market in the UK - MHRA guidance on how to register medical devices to place on the market
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Post-market incidents that are considered vigilance - MHRA guidance for manufacturers on vigilance
The manufacturer does not appear in a search of the MHRA register MHRA Public Access Database for Medical Devices.
A review of the information on the Silvercloud product online, suggests that it might be considered to be a medical device and we will make further enquiries directly with the manufacturer, although we will not be able to provide any further information to you because this will be exempt under section 30 – Investigations of the FOIA 2000. In addition, if we did hold ‘any related documentation’ specific to a manufacturer this would usually be exempt from disclosure according to Section 43 – Commercial interests of the FOIA 2000.
Kind regards,