The MHRA has designated three new UK approved bodies, almost doubling it’s capacity for the certification of medical devices. There are now a total of seven UK approved bodies in the UK. These approved bodies play an important role in the medical device industry by helping manufacturers to get their device on the market and in supporting faster certification of safe and effective medical devices for both healthcare professionals and the general public.
The new approved bodies are TUV SUD BABT Unlimited , Intertek Medical Notified Body UK Ltd and TUV Rheinland UK Ltd.
These new approved bodies have been designated to assess and certify general medical devices in accordance with Part II of the UK MDR 2002. In addition to certifying general medical devices, TUV Rheinland UK Ltd has also been designated to certify in-vitro diagnostics in accordance with Part IV of the UK MDR 2002.
A full list of UK approved bodies, with their scope can be shown in the table below.
Since the list of designated bodies is a dynamic list and subject to change, it is always a good idea to keep updated with the list using the MHRA website. A full list of UK approved bodies can be found using the following link
