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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

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…
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April 24, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Intertek designated as a UK Approved Body

Recently MHRA announced the designation of TUV Rheinland UK Ltd and TUV SUD BABT Unlimited under the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). On 24 August, their webpage was updated again to add the designation of Intertek Medical Notified Body UK Ltd for medical devices. Approved bodies are organisations which the MHRA…
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August 25, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA designates new UK Approved Bodies for Medical and IVD devices

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…
admin
August 18, 2023