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Please note this is an extract of the original bulletin.

The Innovative Devices Access Pathway (IDAP)

Page summary:
The Innovative Devices Access Pathway (IDAP) program is designed to accelerate the development of cost-effective medical devices and their integration in to the UK market.

Change made:
Applications for the Innovative Devices Access Programme (IDAP) pilot now closes 1 November 2023 and further technical advice for applying has been updated.

MHRA to launch the AI-Airlock, a new regulatory sandbox for AI developers

Page summary:
The AI-Airlock will assist in the development and deployment of software and AI medical devices, safely providing patients with earlier access to cutting edge innovations that improve care.

Change made:
First published.

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:
‘List of medical devices given exceptional use authorisations’ and’List of medical devices that are no longer covered by an exceptional use authorisation’ have been updated.

 

Tehelj