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:
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.
The below resources may be of interest to you: