UK MHRA Announces Three New Approved Bodies to Certify Medical Devices

By Karen Hill

On August 29, 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that they had designated three new UK Approved Bodies, almost doubling the UK’s current capacity to certify medical devices.

UK Approved Bodies

Under the current UK legislation, before a manufacturer can place a UKCA-marked medical device on the market in England, Wales and Scotland, they must secure UKCA marking from a UK Approved Body. This applies to all medical devices and IVDs, except those of the lowest risk classification (i.e., Class I medical devices without sterile/measuring functions and general IVDs).

Before appointing a UK Approved Body, the MHRA conducts a detailed assessment to ensure that the organization meets the relevant requirements. Once all conditions are satisfied, the MHRA will designate that organization as a UK Approved Body for a maximum period of five years, during which time they are regularly monitored to ensure they continue to meet the requirements.

New designations

TÜV SÜD, Intertek, and TÜV Rheinland UK have now been added to the list of four previously designated UK Approved Bodies, bringing the total number to seven. All three 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, while TÜV Rheinland UK has also been designated to assess and certify IVDs in accordance with Part IV of the UK MDR 2002.

The full list of currently designated UK Approved Bodies, along with their approved designations is included in the table below.  

Emergo by UL will continue to report on the regulatory landscape in the UK and post updates as they become available.