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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…
The Secretary of State has appointed Ama Agbeze and Nicola Shannon as Board Members of the UK Anti-Doping Agency for a term of 4 years
MHRA sets out new plans to protect patient safety and enable access without delay for UK patients to innovative medical technologies
MHRA tells patients and healthcare professionals to stop using affected gels and retailers told to withdraw affected products.
Public consultation supports proposal to update 3 regulations that ensure the safe and effective delivery of COVID-19 and influenza vaccination programmes.
The Innovative Devices Access Pathway (IDAP) pilot was launched today by the Department of Health and Social Care (DHSC), Health Technology Wales (HTW), the Medicines and Healthcare products Regulatory Agency (MHRA), the Nat…
CE marked medical devices will continue to be accepted on the Great Britain market beyond 30 June 2023
The Innovative Devices Access Pathway (IDAP), set for launch later in 2023, will be operated by the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), He…
The European Parliament has voted to adopt an extension of the transition period for the EU Medical Device Regulations and to extend the validity of certain device certificates
The Minister of State at DHSC has responded to recommendations made by the Regulatory Horizons Council (RHC) on the regulation of medical devices.
The Business Secretary has responded to recommendations made by the Regulatory Horizons Council on the regulation of neurotechnology.
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