Https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/ (Europe Readies for Big.pdf)

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Document Page 1 of 5 Related Articles: 2 This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, click here or call +1 (908) 547-2200. Printed by Mr. Norm Rabin, Maetrics LLC Europe Readies For Big Changes In Device Postmarket Surveillance EU Policy-Makers Set End-OfYear Goal To Finalize Device, Dx Reform “The Gray Sheet” Oct. 15, 2015 EU Device Reform Proposal Adds More Government Scrutiny, But No FDA-Like Review Body “The Gray Sheet” Oct. 1, 2012 By Amanda Maxwell / Email the Author Features & Analysis / Word Count: 1126 / Article # 01160201005 / Posted: January 28 2016 6:00 PM Topics Covered in this Article Executive Summary Click a keyword for related articles. Europe may be on the cusp of a big drive toward a more clearly organized and more transparent postmarket vigilance system with new funds directed at the issue in the wake of device safety scandals. The European Commission recently launched the second phase of its joint action plan of near-term device and diagnostics reforms, pushing postmarket surveillance to the top of its agenda.


         





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