Overhaul of medical device regulations in UK takes effect - Digital Health News - 19 June 2025
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Overhaul of medical device regulations in UK takes effect 🏥
The Medicines and Healthcare products Regulatory Agency’s (MHRA) has announced a major overhaul of how medical devices are regulated in Great Britain as part of a wider transformation of the UK’s medical device regulatory framework.
Under the new Post-Market Surveillance (PMS) regulations, device manufacturers are required to actively track the safety and performance of products already in use to help identify potential safety issues earlier.
The regulatory reform applies to all UKCA- and CE-marked devices placed on the GB market after 16 June 2025, including vitro diagnostic devices (IVD), such as glucose monitors, active implantable medical devices including pacemakers, and technologies used across hospitals, clinics and at home.
Public favours tiered system of access for single patient record 👩⚕️
The public do not want all health and care professionals to have full access to a single patient record (SPR) and would prefer a tiered system of access, according to government research.
NHS England and the Department of Health and Social Care commissioned agency Thinks Insight & Strategy to conduct a large-scale public engagement programme to build and maintain public trust in how data is used across health and social care.
In October 2024, the government announced plans to launch a SPR as part of the NHS 10-year health plan, summarising patient health information, test results and letters in one place, through the NHS App.
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