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

By April 24, 2024No Comments

The Medicines and Healthcare products Regulatory Agency have increased the capacity to process conformity assessments for active implantable medical devices and IVD devices with the addition of LNE-GMED UK Limited to their list of UK Approved Bodies, bringing the total number of UK Approved Bodies in the UK to 9.

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) (UK MDR 2002).

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

Greater approved body capacity should ensure safe and effective devices reach the public faster, and BIVDA welcome LNE-GMED to the market.

Ben Kemp