Anvisa Publishes Guidance Manuals for Medical Device Regularization
Anvisa has published two guidance manuals for the regularization of IVD devices and notification of risk class I and II medical devices, aiming to improve dossier quality and reduce technical requirements and rejections.
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.