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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.

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