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 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 Legal Requirements for Specific Medical Devices
The MHRA has updated its guidance on legal requirements for prosthetic, orthotic and ophthalmic devices, including classification, custom-made devices and examples.
MHRA Updates Guidance on Custom-Made Devices in Great Britain
The MHRA has updated its guidance on custom-made medical devices in Great Britain, covering definitions, conformity assessment, UKCA marking, statements, PMS, vigilance and registration.
MHRA Updates Guidance on Registering Medical Devices for the UK Market
The MHRA has updated its guidance on registering medical devices, IVDs, custom-made devices, systems and procedure packs for the Great Britain and Northern Ireland markets.
MHRA Updates Guidance on Borderlines with Medical Devices and Other Products in Great Britain
MHRA guidance on medical device borderlines in Great Britain, covering intended purpose, UKCA scope and manufacturer considerations.
MHRA Updates Guidance on Medical Device Registration in Great Britain
The MHRA has updated its guidance on registering medical devices in Great Britain, clarifying registration requirements, UK Responsible Person obligations, documentation expectations and procedures for managing registered devices.
MHRA Updates Guidance on Clinical Investigations in Great Britain: Key Implications for Manufacturers
MHRA releases updated 2026 guidance on clinical investigations in Great Britain. Key regulatory impacts for medical device manufacturers under UK MDR.