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Europe Readies For Big Changes In Device Postmarket Surveillance

This article was originally published in The Gray Sheet

Executive Summary

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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