DCB0129 and DTAC Scope Changes
21 July 2024
NHS England are currently reviewing both DTAC and DCB0129 following concerns raised about issues with the current documents. Taking into account the MHRA announcement about recognition by the UK of international regulators’ approvals of medical devices and considering industry feedback, the following is proposed as an template for updates to DTAC and DCB0129.
The items that would be considered in the “Manufacture of Health IT Systems” can be grouped into three categories:
- Medical Devices or accessories falling under the Medical Device regulations, including IVD, which could be hardware, software (including Software as a Medical Device), or a combination of both hardware and software. Typically, these will be developed following an appropriate standard, such as the IEC 60601 series or IEC 62304 (Medical device Software). [Appendix 1, Appendix 2]
- Health Software, as defined in IEC 82304-1. [Appendix 3]
- Software that is not a medical device or not defined as Health Software.
In the case of items 1 and 2 above no additional documentation should be required apart form that mandated by the standards. This will allow safe integration into the Health IT System for their “intended purpose” by following ISO 80001-1:2021 – Application of risk management for IT-networks incorporating medical devices.
Read this document in full here: 040724 DCB0129 and DTAC Scope Changes Final