UK: MHRA Appointed 3 New Approved Bodies for Medical Devices

TÜV SÜD, Intertek, and TÜV Rheinland UK joined in as the latest addition to the UK Approved Bodies announced on 29 August 2023 by the Medicines and Healthcare products Regulatory Agency (MHRA). The existing UK Approved Bodies are BSI Assurance UK, DEKRA Certification UK, SGS United Kingdom, and UL International.

In order to receive approval from MHRA as an Approved Body, MHRA will conduct detailed assessment procedures to ensure the organizations are able to:

• Conduct impartial and objective conformity assessment activities

• Provide an appropriate quality management system

• Contribute the capacity and competence to undertake assessment and processes used to meet the regulatory requirements

TÜV SÜD and Intertek were appointed to assess and certify general medical devices according to Part II of the Medical Devices Regulations 2002, while TÜV Rheinland UK is responsible for assessing and certifying general medical devices and in-vitro diagnostics medical devices in accordance with Part IV of the Medical Devices Regulations 2002.

The additions to the Approved Bodies are almost doubling the UK capacity to certify medical devices and are expected to provide quick support certification of safe and effective medical devices for the UK healthcare industry.

MHRA believes that capacity expansion of the approved bodies is important as the bodies play vital roles in medical devices’ supply to the UK market.

Source: Medicines and Healthcare products Regulatory Agency (MHRA)

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