MHRA Updates Guidance on Reporting Adverse Events

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a bulletin providing new guidance on reporting and disseminating information about adverse incidents involving medical devices.

The guidance, "Reporting Adverse Incidents and Disseminating Medical Device Alerts," replaces a January 2006 document.

It provides information on what is a medical device, what constitutes an adverse event and when to report it, how to report incidents, what to do with devices involved in incidents and how the MHRA responds to and manages reports. It also addresses the dissemination of medical device alerts and field safety notices and corrective actions.

According to the guidance, the MHRA received reports of approximately 8,000 adverse incidents in 2006. Of those, roughly 26 percent required standard investigations and 27 percent necessitated in-depth investigations. The rest were reported as part of the agency's ongoing trend analyses.

The guidance can be viewed at www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2025833&ssTargetNodeId=572 ( http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2025833&ssTargetNodeId=572 ).

( http://www.fdanews.com/ddl/34_14/ )