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Future of EU IVD Regulation – classification, conformity assessment and PMA

This article was originally published in Clinica

Executive Summary

Clinica’s second bite-size table looks at how the new EU IVD Regulation, proposed by the European Commission in September 2012 and currently being debated in Parliament, will impact industry and regulators. The easy-to-use reference table also compares the proposed regulations with the current requirements.

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