DTAC is the Digital Technology Assessment Criteria for health and social care produced by NHS X. Essentially the document is a long questionnaire which asks suppliers of health IT systems to explain how they ensure that their product is safe and secure.

Section C1 of DTAC asks about Clinical Safety and Medical Device Regulation. To complete these sections you will need to have complied with DCB 0129 and have established a firm position on whether or not your product qualifies as a Medical Device.

Safehand support for DTAC compliance

You will need to have a Clinical Safety Officer in place (a clinician, specially trained in risk management) and have undertaken a DCB 0129 compliance project to create the necessary documentation. In practice, the most efficient way to achieve this is to outsource these tasks to an expert. See our pages below on how our staff of ten Clinical Safety Officers support over 80 organisations with DCB 0129 compliance:

Some health IT systems qualify as Medical Devices under UK and EU law. You will either need to provide justification as to why your product is not a Medical Device or demonstrate that you have complied with the appropriate regulations. Either way this process can be complex and getting this wrong is potentially a criminal offence under both UK and EU law.

We can help you to establish an informed decision and assist you with the appropriate CE/UKCA Marking if required.