Please note this is an extract of the original bulletin.
CE marking recognition for medical devices and in vitro diagnostics
Page summary:
The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics.
Change made:
First published.
Medical devices: guidance for manufacturers on vigilance
Page summary:
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
Change made:
Guidance updated to reflect the latest information regarding the MORE portal.
Register medical devices to place on the market
Page summary:
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
Change made:
Updated – Account Management Reference Guide & Device Registration Reference Guide.
Export medical devices
Page summary:
Order a certificate of free sale to export medical devices outside the UK.
Change made:
Updated ‘Certificates of Free Sale for Medical Devices’.
