MHRA

New MHRA CEO puts safety, accelerated access and innovation at the centre of agency’s refreshed strategic direction.

List of Field Safety Notices from 9 to 13 June 2025

A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

Since, April 2024, the MHRA has been using Lorenz DocuBridge for eCTD management in product license submissions. This change is part of the modernisation of the MHRA’s Legacy Systems and is one of the initial tools launched in the RegulatoryConnect programme.

New Post-Market Surveillance (PMS) regulations have taken effect across Great Britain, requiring medical device manufacturers to proactively monitor the safety and performance of their products once on the market.

Guidance for manufacturers of IVC filters. It outlines specific scenarios that should be considered when determining if an incident is reportable.

A flyer to circulate to customers alongside a field safety notice covering what it is and why it’s important to take action.

Guidance for manufacturers of artificial heart valves. It outlines specific scenarios that should be considered when determining if an incident is reportable.

Guidance for manufacturers of cardiac implantable electronic devices and their leads. It outlines specific scenarios that should be considered when determining if an incident is reportable.

How to write clear and effective field safety notices (FSNs) for medical devices.

Guidance for manufacturers of coronary stents. It outlines specific scenarios that should be considered when determining if an incident is reportable.