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MHRA: Designation of Two New UK Approved Bodies

MHRA: Designation of Two New UK Approved Bodies

On 31 January 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the designation of two new UK Approved Bodies (UKAB) to increase the capacity to certify the performance and safety of medical devices.

The two new Bodies are:

  • LNE-GMED UK, responsible for the certification of general medical devices in accordance with Part II of the UK MDR 2002.
  • SCARLET NB UK, designated to certify software and AI as a medical device (AI/SaMD).

Previously, UL International UK and TÜV SÜD, two other UKABs, had their scope expanded.

From now on, there are nine active Approved Bodies for the certification of medical devices in the UK. The MHRA monitors their activities on an ongoing basis by conducting and witnessing audits.


MHRA: Press Release