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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:
Reference guides and the videos ‘update devices and update products individually’ and ‘review and renew registration’ have been updated.

MHRA / HRA Coordinated pathway

Page summary:
The Coordinated pathway process resumed Monday 22 May 2023.

Change made:
First published.

Windsor Framework medicines announcement*

Page summary:
New measures to commence 1 January 2025.

Change made:
First published.

*This update does not include information on medical devices

The Windsor Framework – further detail and publications*

Page summary:
This page sets out further detail on how the Windsor Framework will work in practice as the new arrangements are implemented.

Change made:
First published.

*This update does not include information on medical devices

COVID-19 test validation approved products

Page summary:
Find out which COVID-19 test products have been approved.

Change made:
Updated ‘COVID-19 test validation approved products’ file.

Software and AI as a Medical Device Change Programme

Page summary:
The Medicines and Healthcare products Regulatory Agency (MHRA) have embarked upon an ambitious programme of reform to ensure that medical device regulation is fit for purpose for software, including artificial intelligence (AI).

Change made:
Partnerships section updated.

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 information on ‘MHRA / HRA Coordinated pathway’ – Resuming Monday 22 May 2023.

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