House of Commons · Written Ministerial Statement
Legal Transfer for Software Medical Devices
07 July 2026 · Department of Health and Social Care
Proposed by Preet Kaur Gill Lab Birmingham, Edgbaston
Summarised by AI from the official record, so it can contain mistakes.
At a glance
Key points
- The legal responsibility for software medical devices will transfer from NHS England to the Department of Health and Social Care.
- The Department of Health and Social Care will ensure compliance with existing regulations and maintain robust standards.
- The Department will oversee governance arrangements and accountability for these devices post-transfer.
Issue summary
The statement addresses the planned transfer of legal responsibility for software medical devices from NHS England to the Department of Health and Social Care.
Action requested
The Minister confirms that the Department will ensure compliance with existing regulations and maintain robust standards, governance arrangements, and accountability in overseeing these critical services post-transfer.
Key facts
- Under the Medical Devices Regulations 2002, NHS England is currently the legal manufacturer for software medical devices.
- Responsibility for these devices will be transferred to the Department of Health and Social Care following the abolition of NHS England.
- The Medicines and Healthcare products Regulatory Agency will have a role in governance arrangements.
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Assessment & feedback
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