Overview

There are now nine UK Approved Bodies available. The full list is available: HERE

This month the MHRA newly designated LNE-GMED UK Limited and Scarlet NB UK Ltd as UK Approved Bodies. Note that Scarlet NB UK Ltd’s scope is limited to medical device software, which is their area of specialty.

Previously, the following UK Approved Bodies were designated:

• BSI, UL, SGS – grandfathered in as part of Brexit
• DEKRA – designated September 2022
• TUV SUD, TUV Rheinland, and Intertek – designated August 2023

This is in preparation for the MHRA’s intent to phase out the CE Marking transition period by June 2030. However, the MHRA also stated it plans to establish a framework for international recognition, which will include regulators such as the US FDA. Therefore, it remains to be seen how UKCA Marking, the end of the CE Marking transition period, and the international recognition program will all tie together, in the coming years.

Additional Reading

The below resources may be of interest to you:

• UK Medical Device: Registration Steps, Time, and Cost
• UKCA Marking: Fact Sheet for Medical Devices & IVDs
• Is there any advantage to UKCA Marking early?
• Steps Required to Sell Medical Devices in the UK