MHRA Updates Guidance on Submitting Clinical Investigation Proposals for Assessment
MHRA has updated its guidance on submitting clinical investigation proposals, covering GB and Northern Ireland requirements, IRAS submission, supporting documentation, fees, device evidence, software, biological safety and sterilisation.
MHRA Updates Guidance on Clinical Investigations for Medical Devices
The MHRA has updated its guidance on clinical investigations for medical devices, covering notification requirements, fees, applications, assessment, amendments, reporting and Northern Ireland requirements.
MHRA Updates Guidance on Determining Whether a Clinical Investigation Is Required
The MHRA has updated its guidance on determining whether a clinical investigation is required for medical devices in Great Britain, covering pre-clinical testing, PMCF, medical purpose, research tools and notification requirements.
MHRA Updates Guidance on Clinical Investigations and Introduces 2026–2027 Fee Waiver Pilot
MHRA updates its clinical investigations guidance and introduces a 2026–2027 fee waiver pilot for SMEs. Key requirements for medical device manufacturers explained.
MHRA Issues Updated Guidance on Submitting Clinical Investigation Proposals
MHRA releases new 2026 guidance on clinical investigation submissions via IRAS. Key requirements, timelines, and implications for manufacturers.