Executive Intelligence
Life Sciences Reports
Regulatory, funding, leadership, market and commercial updates selected for life-science executives.
Guidance: Magnetic resonance imaging equipment in clinical use: safety guidelines
Relevant safety information for users of magnetic resonance imaging (MRI) equipment in clinical use.
Read full reportThousands of patients to benefit from new daily pill for serious heart condition following co-ordinated MHRA and NICE decisions
Aficamten is recommended by NICE at the same time it was approved by the MHRA, thanks to improvements driven by closer working between the two organisations.
Read full reportPioneering AI health innovations regulatory sandbox launched
The London sandbox is a secure environment designed to safely test AI-enabled devices in a real-world environment so patients can benefit more quickly.
Read full reportTransparency data: MHRA Performance Data
Performance data for MHRA key performance indicators (KPIs) and information on the expected timeline to complete a specific regulatory function.
Read full reportDecision: Marketing authorisations Granted in 2026
Marketing authorisations granted in 2026.
Read full reportDecision: Parallel import licences granted in 2026
Parallel import licences granted in 2026.
Read full reportGuidance: London Region I MHRA Regulatory Sandbox: call for expressions of interest
Expressions of interest are invited from AI-enabled medical device manufacturers and NHS provider organisations interested in participating in the London Region I MHRA Regulatory Sandbox.
Read full reportFDA Licenses First-Ever Freeze-Dried Plasma Product in the U.S.
FDA today licensed Ezplaz Freeze Dried Plasma (FDP), making it the first freeze-dried plasma product licensed for use in the United States. Ezplaz is intended for transfusion in adult patients who need plasma and for whom other plasma products are not available.
Read full reportBeat the heat: MHRA urges people to take extra care with medical devices this summer
Simple steps to help keep your essential medical equipment working safely when temperatures rise.
Read full reportField Safety Notices: 29 June to 03 July 2026
List of Field Safety Notices from 29 June to 03 July 2026
Read full reportMHRA clarifies regulatory status of ambient voice technologies used in the NHS
The Medicines and Healthcare products Regulatory Agency has published guidance, developed in close partnership with NHS England, clarifying how existing medical device law applies to ambient voice technology (AVT) products used in health and care settings in Great Britain.
Read full reportGuidance: Ambient voice technology-enabled products
Device qualification and classification of ambient voice technology-enabled products that are medical devices intended to be placed on the market, or put into service, in Great Britain.
Read full reportGuidance: Digital mental health technology: qualification and classification
Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.
Read full reportField Safety Notices: 20 to 24 July 2026
List of Field Safety Notices from 20 to 24 July 2026.
Read full reportSafety Public Assessment Reports
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Read full reportResearch: Bladder Anticholinergics: review of risk of dementia
Public Assessment Report on the safety review of the available data on the risk of dementia with the use of bladder anticholinergic medicines.
Read full reportResearch: Bladder Anticholinergics: review of risk of dementia
Public Assessment Report on the safety review of the available data on the risk of dementia with the use of bladder anticholinergic medicines.
Read full reportMeeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2026
Twelve new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended twelve medicines for approval at its July 2026 meeting.The committee…, CHMP statistics Key figures from the July 2026 CHMP meeting are represented in the graphic below. © European Medicines Agency , CHMP statistics:…, Positive…
Read full reportNo Summer Shortcut for Safe Weight Loss
Healthy weight loss takes time, not shortcuts. As demand for weight-loss medicines continues to rise, the MHRA is reminding people how to use GLP-1 medicines safely, spot illegal sellers and avoid diet changes that could interfere with their medicines.
Read full reportGuidance: Clinical investigations: compiling a submission
How to notify the MHRA that you are going to undertake a clinical investigation of a medical device.
Read full reportGuidance: Medical devices that need a clinical investigation
How to determine if you will need to undertake a clinical investigation of a medical device, or if it is exempt under the regulations.
Read full reportClinical investigations for medical devices
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Read full reportClinical investigations in Great Britain
How manufacturers should undertake a clinical investigation for a medical device to ensure they comply with medical device regulations.
Read full reportGuidance: Approving clinical investigations
How the MHRA decides whether to approve a clinical investigation for medical devices.
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