Freedom of Information request on the regulatory impact assessment for the future UK medical device regulations (FOI 22/804)
Published 4 January 2024
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-25-july-2022/freedom-of-information-request-on-the-regulatory-impact-assessment-for-the-future-uk-medical-device-regulations-foi-22804
FOI 22/804
26th July 2022
Dear
Thank you for your information request, dated 26th June 2022, where you asked for a copy of the regulatory impact assessment for the future UK medical device regulations.
Unfortunately, the information is exempt from release under section 35:
Section 35 – Formulation of Government policy: the information you have requested is being withheld under section 35 of the FOI Act. Section 35 protects the internal deliberative process as it relates to Government policy making. In other words, the exemption is intended to ensure that the possibility of public exposure does not deter from full, candid and proper deliberation of policy formulation and development, including the exploration of all options, the keeping of detailed records and the taking of difficult decisions. Section 35 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information. In favour of disclosure, we consider that there is a general public benefit from access to the regulatory impact assessment and this will be published alongside the Statutory Instrument once it is available for publication. However, we consider that the public interest will be better served by not releasing the information as premature disclosure of this sort of information could prejudice good working relationships, the neutrality of civil servants and, ultimately, the quality of Government.
If you have a query about the information provided, please reply to this email.
Yours sincerely,
MHRA Customer Experience Centre