DCB0129 and DTAC Issues and Scope Changes

15 January 2025

AXREM and many other organisations have raised concerns about both DTAC and DCB0129.

Since NHS England are currently reviewing both DTAC and DCB0129, following concerns raised
about issues with the current documents, and taking into account the MHRA announcement
about recognition by the UK of international regulators’ approvals of medical devices, the
following is proposed as an template for updates to DTAC and DCB0129.

An immediate and positive action to the current issues would be to remove certified
medical devices from the scope of DTAC and DCB0129. This would have no effect on
device safety.

The documents details all of the above.

150125 DCB0129 and DTAC Issues and Scope Changes Document FINAL