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.