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Please note this is an extract of the original bulletin.

Impact of AI on the regulation of medical products

Page summary:
Implementing the Artificial Intelligence (AI) White Paper principles.

Change made:
First published.

MHRA’s AI regulatory strategy ensures patient safety and industry innovation into 2030

Page summary:
The MHRA has today set out its strategic approach to artificial intelligence (AI)

Change made:
First published.

Send and receive information on adverse drug reactions (ADRs)

Page summary:
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.

Change made:
Updated with information about new MHRA systems.

Medical devices given exceptional use authorisations during the COVID-19 pandemic

Page summary:
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.

Change made:
Updated list of medical devices given exceptional use authorisations

Digital mental health technology: user and public perspectives

Page summary:
A research report on attitudes to digital mental health technology.

Change made:
First published.

Software and artificial intelligence (AI) as a medical device

Page summary:
Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).

Change made:
Update to the digital mental health technology section.

 

Tehelj