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Data, Freedom of Information releases and corporate reports
Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).
Overview Software (including AI) plays an essential part in health and…
The Wellcome Trust has funded a 3-year project focusing on effective regulation and evaluation of digital mental health technology.
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
Manufacturer: BIRR BioSciences BIRR BioSciences products Issue date: 2 May…
Manufacturer: Medtronic Ltd Medtronic Spinal Cord Stimulation Extensions…
The MHRA has authorised cabotegravir as 30 mg tablets and as a 600 mg long-acting injection administered every two months
A research report on attitudes to digital mental health technology.
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
Department of Health and Social Care and MHRA register of electronic export certificates (human).
List of Field Safety Notices from 22 to 26 April 2024.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
The MHRA has today set out its strategic approach to artificial intelligence (AI)
Implementing the Artificial Intelligence (AI) White Paper principles.
Further measures to be introduced to ensure patients who are prescribed montelukast for the treatment of asthma are informed of the risk of neuropsychiatric reactions
The MHRA will introduce a patient alert card to increase awareness among men taking finasteride about potential psychiatric and sexual side effects
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor, the Commission on Human Medicines
A patient alert card is being introduced for men taking finasteride to help raise awareness of the risk of psychiatric side effects and sexual dysfunction, including the potential for sexual dysfunction to persist after trea…
Healthcare professionals prescribing montelukast should be alert to the risk of neuropsychiatric reactions in all patients including children and adolescents. Reported neuropsychiatric reactions include sleep disorders, hall…
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Public Assessment Report of review of Finasteride safety data and expert advice on management of risks.
How to contact MHRA for specific services or enquiries.
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