After nearly eight years, the European Parliament endorsed the new In Vitro Regulation and the new Medical Device Regulation. The intent of the new regulations is to strengthen patient safety and provide clarity around access to new and innovative technologies. This article provides an overview of these new regulations.
August 31, 2017 Articles
A Brief Look at the European Union’s New Medical Device and In Vitro Diagnostic Regulations
By Daniel S. Wittenberg and Cassie Redlingshafer
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