Please note this is an extract of the original bulletin.
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.
COVID-19 test validation approved products
Page summary:
Find out which COVID-19 test products have been approved.
Change made:
The correct spreadsheet of COVID-19 test validation approved products has been uploaded.
Medical devices given exceptional use authorisations during the COVID-19 pandemic
Page summary:
List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.
Change made:
Updated: ‘List of medical devices given exceptional use authorisations’ &’List of medical devices that are no longer covered by an exceptional use authorisation’
Software and Artificial Intelligence (AI) as a Medical Device
Page summary:
Information for manufacturers, healthcare organisations and professionals, researchers, and patients & public on Software as a Medical Device (SaMD), including Artificial Intelligence as a Medical Device (AIaMD).
Change made:
The report that was added to the Artificial Intelligence section has been temporarily removed for necessary corrections.
Implementation of medical devices future regime
Page summary:
We are aiming for core aspects of the future regime for medical devices to apply from 1 July 2025.
Change made:
Updated guidance to reflect that the the World Trade Organisation (WTO) has published the draft Post Market Surveillance Requirements Statutory Instrument.
Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework*
Page summary:
Information on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework.
Change made:
First published.
*This update does not include information on medical devices
The Windsor Framework – further detail and publications*
Page summary:
Further detail on the arrangements giving effect to the Windsor Framework.
Change made:
Updated with new guidance links.
*This update does not include information on medical devices
