This Government are committed to ensuring the safe, reliable and effective operation of our critical national infrastructure and our national health service.
Under the Medical Devices Regulations 2002, NHS England is currently the legal manufacturer for software medical devices that underpin essential national services, including systems supporting urgent and emergency care such as NHS 111 and 999. These tools play a vital role in delivering care to patients and supporting the day-to-day functioning of our health system.
Following the planned abolition of NHS England, responsibility for these software medical devices would be transferred to the Department of Health and Social Care. These services will continue to be available to users without disruption.
As the legal manufacturer, NHS England currently undertakes responsibility for ensuring these devices meet required standards of safety and performance.
Following the transfer, the Department of Health and Social Care will continue to fulfil these responsibilities, maintaining the same focus on assurance, patient safety and regulatory compliance.
I am hereby confirming that the Department will ensure compliance of these devices with the Medicines and Medical Devices Act 2021 and the Medical Devices Regulations 2002.
This approach reflects the Government’s commitment to upholding robust standards while ensuring continuity of these critical services.
Appropriate governance arrangements will be put in place with the Medicines and Healthcare products Regulatory Agency to support independence and accountability in the ongoing oversight of these devices.
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