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UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA designates new UK Approved Body IVD devices and active implantable medical devices

By April 24, 2024No Comments

The MHRA have increased their capacity to process conformity assessments for active implantable medical devices and IVD devices with the addition of LNE-GMED UK Limited to their existing list of UK Approved Bodies.

Approved bodies are organisations which the MHRA have designated to assess whether manufacturers and their medical devices meet the requirements set out in the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

The UKAB recognition for LNE-GMED UK Limited allows them to conduct assessments for medical devices, in-vitro diagnostics medical devices as well as active implantable medical devices to ensure their compliance with the requirements of the UK MDR 2002.

This is a significant milestone to ensure that safe and effective devices can reach the public faster. This brings the total number of UK Approved Bodies in the UK to 9, with 5 covering IVDs.