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Legal Transfer for Software Medical Devices
07 July 2026
Type
Written Ministerial Statement
Department
Department of Health and Social Care
TAGS
At a Glance
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
Summary accuracy