Freedom of Information request on Medical Devices and submissions via the IRAS portal (FOI 22/739)
Published 21 December 2023
© Crown copyright 2023
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-11-july-2022/freedom-of-information-request-on-medical-devices-and-submissions-via-the-iras-portal-foi-22739
FOI 22/739
11th July 2022
Dear
Thank you for your information request, dated 31 May, where you asked for “I am writing to you with regards to making a Freedom of Information request regarding Medical Devices and submissions via the IRAS portal.
This is for both Clinical Investigation and In-House exemptions (Health Institution Exempt) submissions, for the past 5 years - requesting specifically IRAS applications for ‘Clinical study of a non-UKCA/CE UKNI/CE marked device where commercialisation of the product is intended’ and ‘Clinical study of a non-UKCA/CE UKNI/CE marked device for use within the institution, where commercialisation is not intended’ within the IRAS portal.
If possible, the result of the submissions in addition, i.e. whether or not a Letter of No Objection was granted”
I can confirm that the MHRA does hold some of the information that you have requested. However, we have also determined that the information is exempt under Section 12 of the Freedom of Information Act and we cannot process your request any further.
Section 12 of the Act allows public authorities to refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information.
In order to process your request, we would need to extract data from multiple internal data systems as all of the information is not currently held in one place. We consider that this would take longer than 24 working hours to complete.
We advise that you narrow your request by, for example, the number of approvals or rejections in one calendar year which is more easily accessible
Please note that substantially similar requests made within 60 working days of an original request can be aggregated into one for the purposes of calculating a cost limit, meaning that section 12 could still apply.
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.
If you have a query about the information provided, please reply to this email.
Yours sincerely
MHRA Customer Experience Centre