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 have designated to assess whether manufacturers and their medical devices meet the requirements set out in the UK MDR 2002.
Intertek Medical Notified Body UK Ltd is designated for medical devices only, and their scope does not include IVDs.
This brings the total number of UK Approved Bodies in the UK to 7, with 4 covering IVDs.
