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.