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Existing emergency measures banning the sale and supply of puberty-suppressing hormones will be made indefinite, following official advice from medical experts.
The pilot scheme, AI Airlock, is designed to help test and improve the rules for AI-powered medical devices to ensure they reach patients quickly, safely and effectively.
Responses will help shape reforms that will boost UK patients’ access to safe and innovative medical products
The ninth annual #MedSafetyWeek takes place this week, with regulators from 94 countries and 107 organisations taking part across the globe.
The new legislation will introduce clearer and risk-proportionate requirements that improve the safety of medical devices across Great Britain and provide certainty for manufacturers ahead of introducing the wider future reg…
The Medicines and Healthcare products Regulatory Agency (MHRA) is asking patients who use a continuous glucose monitor (CGM) or insulin pump to report any safety problem with their device through the MHRA Yellow Card scheme …
The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched its ambitious new business plan for 2024/25, setting out the agency’s core focus of enabling access to innovative healthcare products while en…
New strategy aims to transform the way we provide information on the risks and safety of medicines and medical devices.
Men taking valproate and their partners are being advised by the Medicines and Healthcare products Regulatory Agency (MHRA) to use effective contraception because of new data suggesting a potential small increased risk of ha…
Temporary ban on prescription and supply of puberty blockers extended.
This initiative signals an important step towards a new regulatory framework for medical devices in Great Britain which protects public health, ensures access to MedTech innovations, and maintains an attractive market for in…
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (21 May 2024) launched a four-week consultation which will support improved safety for certain high risk in vitro diagnostic (IVD) devices.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (9 May 2024) launched AI Airlock, its new regulatory sandbox for AI as a Medical Device (AIaMD).
An MHRA and NICE partnership, funded by Wellcome, is addressing key challenges for regulating and evaluating digital mental health technologies (DMHTs) with input from patients, the public and mental health professionals.
Batches of some products made by Legency Remedies Pvt Ltd have been found to contain a bacteria called Ralstonia pickettii (R. pickettii). All potentially affected batches are being recalled following an MHRA investigation.
The UK suspension of the MAGEC system (modified MAGEC X system only) has been lifted as of 23 February 2024
The MHRA welcomes the publication of Dame Margaret Whitehead’s Equity in Medical Devices: Independent Review
Government outlines action to make UK a world leader in tackling ethnic and other biases in medical devices.
First published during the 2022 to 2024 Sunak Conservative government
The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies, delivering increased capacity for the certification of the performance and safety of medical devices, for healthcare p…
Following a review of the effectiveness of current measures to reduce the risk of potentially long-term or irreversible side effects associated with fluoroquinolone antibiotics, the MHRA has introduced further restrictions t…
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