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.
