Several technologies in use in the NHS are operating under a low-risk form of regulation, despite being advertised for remote monitoring of patients’ vital signs, HSJ can reveal.
An HSJ analysis of registrations with the Medicines and Healthcare products Regulatory Agency (MHRA) has found wide variation in the classification of remote monitoring systems – with some complex software operating on the same level of risk assessment as a bandage or needleless syringe.
The systems use wearable devices to track vital signs, blood sugar levels, medicine adherence and other health observations outside hospital, with the aim of triggering an intervention when patients are at risk.
Between November 2020 and January 2023, over 487,000 people were supported at home using the technologies, and the government is pledging a big expansion.
Some of the most widely used platforms are listed with the MHRA as “Class I” devices – the category for devices with the ”lowest risk”, which can be self-certified by manufacturers, and is subject to minimal external oversight.
Suppliers said cost and a shortage of “notified bodies”, which can review applications, held them back from obtaining higher accreditation.
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Source: HSJ, 11 November 2025
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