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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:
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.

Medical devices: EU regulations for MDR and IVDR (Northern Ireland)

Page summary:
Information about the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR), and their implementation in Northern Ireland

Change made:
Updated to include Medical devices: Clinical investigations and performance studies in Northern Ireland replacing Temporary Disapplication of Sponsors and Legal Representatives in Northern Ireland.

Notify the MHRA about a clinical investigation for a medical device

Page summary:
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.

Change made:
Updated to include Medical devices: clinical investigations and performance studies in Northern Ireland replacing Temporary Disapplication of Sponsors and Legal Representatives in Northern Ireland.

 

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