TÜV SÜD, Intertek, and TÜV Rheinland UK join the four current UK Approved Bodies, almost doubling current capacity for the certification of medical devices in the UK.
TÜV SÜD and Intertek have been designated as UK Approved Bodies to assess and certify general medical devices in accordance with Part II of the UK Medical Devices Regulations 2002. TÜV Rheinland UK has also been designated to assess and certify general medical devices as well as in-vitro diagnostics in accordance with Part IV.
With the exception of the very lowest risk devices, manufacturers must apply to a UK approved body for UKCA certification. Products can only be placed on the market in England, Wales and Scotland after they have achieved certification…
