News and communications

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).

• Updated: 9 May 2024

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.

• Updated: 7 May 2024

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.

• Updated: 5 April 2024

The UK suspension of the MAGEC system (modified MAGEC X system only) has been lifted as of 23 February 2024

• Updated: 12 March 2024

The MHRA welcomes the publication of Dame Margaret Whitehead’s Equity in Medical Devices: Independent Review

• Updated: 11 March 2024

Government outlines action to make UK a world leader in tackling ethnic and other biases in medical devices.

• Updated: 11 March 2024

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…

• Updated: 31 January 2024

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…

• Updated: 22 January 2024

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

• Updated: 10 January 2024

MHRA sets out new plans to protect patient safety and enable access without delay for UK patients to innovative medical technologies  

• Updated: 9 January 2024

MHRA tells patients and healthcare professionals to stop using affected gels and retailers told to withdraw affected products.

• Updated: 24 November 2023

Public consultation supports proposal to update 3 regulations that ensure the safe and effective delivery of COVID-19 and influenza vaccination programmes.

• Updated: 30 October 2023

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…

• Updated: 19 September 2023

CE marked medical devices will continue to be accepted on the Great Britain market beyond 30 June 2023

• Updated: 1 July 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…

• Updated: 26 May 2023

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

• Updated: 9 May 2023

The Minister of State at DHSC has responded to recommendations made by the Regulatory Horizons Council (RHC) on the regulation of medical devices.

• Updated: 26 January 2023

The Business Secretary has responded to recommendations made by the Regulatory Horizons Council on the regulation of Artificial Intelligence (AI) as a Medical Device.

• Updated: 30 November 2022

The Business Secretary has responded to recommendations made by the Regulatory Horizons Council on the regulation of neurotechnology.

• Updated: 30 November 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have been awarded £1.8m funding by Wellcome over three years to explore and produce guidance on …

• Updated: 10 October 2022