The MHRA has updated its guidance on clinical investigations for medical devices, covering notification requirements, fees, applications, assessment, amendments, reporting and Northern Ireland requirements.

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.

The MHRA has updated its guidance on legal requirements for prosthetic, orthotic and ophthalmic devices, including classification, custom-made devices and examples.

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.

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.

The MHRA has updated its list of UK approved bodies authorised to undertake conformity assessments for medical devices under the UK MDR 2002.

MHRA guidance on medical device borderlines in Great Britain, covering intended purpose, UKCA scope and manufacturer considerations.

MHRA updates guidance on regulating medical devices in Great Britain and Northern Ireland. Key rules on UKCA, CE marking and registration.

New MHRA guidance summarises UK conformity routes for all medical device classes. Essential for UKCA compliance and UK MDR planning.

The MHRA has published updated guidance on clinical investigations for medical devices, detailing the requirements manufacturers must meet when planning and conducting investigations in Great Britain. The update strengthens documentation expectations, safety requirements and regulatory oversight, making it essential for all manufacturers preparing UK submissions.