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Scrip Regulatory Affairs
New Demands Edge Closer for Clinical Trial Safety Reporting in the EU
14 May 2010
Danielle Giroud

The implementation deadline of 21 March has gone by and new safety reporting requirements for clinical investigations are now in place throughout the European Union.

As a result of the revisions made to the medical device directives by Directive 2007/47 EEC, all serious adverse events (SAEs) must be fully recorded and immediately notified to all competent authorities of the member states in which the clinical investigation is being performed...

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