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News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
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Data, Freedom of Information releases and corporate reports
Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.
Collecting and acting on information on any adverse effects of electronic cigarette devices and refill containers on human health.
General advice on vigilance - electronic cigarettes devices and refill containers.
Guidance for manufacturers of artificial heart valves. It outlines specific scenarios that should be considered when determining if an incident is reportable.
Information for manufacturers of software as a medical device, detailing events that may cause indirect harm and are therefore 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.
Guidance for manufacturers of IVC filters. It outlines specific scenarios that should be considered when determining if an incident is reportable.
Guidance for manufacturers of coronary stents. It outlines specific scenarios that should be considered when determining if an incident is reportable.
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