Please note this is an extract of the original bulletin.
In vitro diagnostic medical devices: guidance on legislation
Page summary:
Guidance explaining the main features of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) in relation to in vitro diagnostic medical devices
Change made:
In vitro diagnostic medical devices: guidance on legislation file updated.
How tests and testing kits for coronavirus (COVID-19) work
Page summary:
The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
Change made:
The guidance ‘For industry and manufacturers: COVID-19 tests and testing kits’ was updated to include the correct email address for further information about CTDA ctda@mhra.gov.uk
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 and template for extended CE certificate validity under EU MDR Article.
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:
Registrations guidance links updated.
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:
Implementation of the Future Regulations updated to include note on the reviewing of our position on the acceptance of EU MDR and EU IVDR CE certificates.
