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Clinica Top 10: The Hottest European Regulatory Topics In March

This article was originally published in The Gray Sheet

Executive Summary

News of a break in the logjam over a prospective premarket "scrutiny" process for high-risk medical devices in Europe captured the most attention last month by readers of Clinica, a London-based sister publication to The Gray Sheet. Coverage of notified body struggles, the impact in Europe from the revised ISO 13485 quality systems standard, and potential medtech implications of a British exit from the EU were also popular.

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