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Please note this is an extract of the original bulletin.

Regulating medical devices in the UK

Page summary:
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.

Change made:
Published overview of timelines for placing CE marked IVDs on the Great Britain market

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:
Published overview of timelines for placing CE marked IVDs on the Great Britain market

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:
Updated guidance on registration of certain medical devices which are reusable Class I devices, upclassified Class I devices, and/or reliant on expired/expiring CE certificates.

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.

 

Tehelj