The UK regulator MHRA has confirmed three new organisations as Approved Bodies in the UK, increasing the number that can certify medical devices from four to seven.

This will significantly increase the UK's capacity to certify medical devices and is an important step in the UK Government's strategy to ease the route to market for companies looking to introduce new products.

TÜV SÜD and Intertek have been designated to assess and certify general medical devices. TÜV Rheinland UK has been designated to assess and certify general medical devices as well as in-vitro diagnostics.

Medical devices are classified under the Medical Devices Regulations 2002 (as Class I, IIa, IIb or III)  according to their use and associated risk to patients. With the exception of the lowest risk devices, manufacturers must apply to a UK Approved Body for UKCA certification before the device can be placed on the market. 

Prior to Brexit this requirement was for CE certification. The UK is currently in a transition period where CE markings will still be accepted for defined periods of time depending on how medical devices obtained their CE marking and whether they are used for in-vitro diagnostics. Please see our previous article for the precise dates of the transition period.  

Please contact our Healthcare team if you are looking to bring a product to market or have any questions about medical device regulation.