Module 17 2024

05/12/2024

Chapter 7: Clinical Investigations

Application for clinical investigations The detailed requirements for the clinical investigation application form and the accompanying documentation required are included in the regulations Relevant timescales that the applicant and the MHRA should conform to when an application for a clinical investigation is submitted to the MHRA. The existing 60 calendar-day timescale for assessment for clinical investigations will remain in place. The MHRA consider it important to set these requirements out in legislation to provide clarity and to support compliance. We will provide supplementary guidance to support manufacturers and sponsors.

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Chapter 7: Clinical Investigations

Assessment of applications for clinical investigation by the MHRA • The regulations will set out the detailed requirements for the assessment of the application for a clinical investigation by the MHRA • The regulations will set requirements for the conduct of a clinical investigation Clinical investigations regarding devices bearing the UKCA marking In certain cases, a sponsor will be required to notify the MHRA within a specified timeframe (30 calendar days) prior to the start of a study, in cases where a clinical investigation is to be conducted to further assess a device which is already UK Conformity Assessed (UKCA) marked according to its intended purpose

The Organisation for Professionals in Regulatory Affairs

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