This Government is committed to ensuring the safe, reliable and
effective operation of our critical national infrastructure and
our National Health Service.
Minister for Health Innovation and Safety (): 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 for 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.
