Did You Know?

Did you know1 that the UK's MHRA (Medicines and Healthcare Regulatory Agency) expects 98 percent of adverse event reports related to faulty or malfunctioning medical devices to be submitted by March 31, 2010? The MHRA also specifies that the event reports must be submitted in an electronic format.

This mandate, as most medical device companies and MHRA regulators can predict, won't be simple but can be mad less complex with the newly introduced web-based reporting system that will soon be launched by MHRA and will include alert mechanisms.

In addition to the new system, the MHRA has also set for itself the ambitious goal of a 100 percent response to every serious or fatal adverse event related to a faulty or malfunctioning medical device.


1. The information in this content was paraphrased from the following article: http://www.fdanews.com/newsletter/article?articleId=117129&issueId=12661

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