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

MHRA designates new UK Approved Bodies for Medical and IVD devices

By August 18, 2023No Comments

The MHRA have increased their capacity to process conformity assessments for medical and IVD devices with the addition of TUV Rheinland UK Ltd and TUV SUD BABT Unlimited 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).

TUV SUD BABT Unlimited can now undertake conformity assessments for medical devices. Whereas the UKAB recognition for TUV Rheinland UK Ltd allows them to conduct assessments for both medical devices and in-vitro diagnostics 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.