DCB0129 and DTAC Issues and Scope Changes Statement

15 January 2025

AXREM and many other organisations have raised concerns about both DTAC and DCB0129. AXREM have today published a DTAC Issues and Scope Changes Statement outlining the challenges and potential solutions in detail, this is following the association first raising issues around DTAC/ DCB0129 in the spring of 2023.

To read or download this document in full: DCB0129 and DTAC Issues and Scope Changes – AXREM

Problem Overview

AXREM members are increasingly concerned about the use of DTAC (Digital Technology Assessment Criteria) and DCB0129 (Clinical Risk Management: its Application in the Manufacture of Health IT Systems) due to multiple issues, which are leading to confusion and excessive workload both for AXREM members and the NHS.

Many of the issues have resulted from changes made to the DTAC document that expanded the questions to include products which were well outside the original intended scope of user facing applications. This along with a lack of any formal scope, missing clear definitions, absence of differentiation between new and established products, inappropriate questions, and poor granularity depending on the type of product (e.g., a certified medical device should need almost no questions once it has been identified), results in confusion, duplication, wasted time, and costs for both suppliers and the NHS. In many cases the DTAC provides no useful or actionable information and simply becomes a tick box exercise for the purchaser.