The transition from complying with the EU IVDD 98/79/EC to meeting the requirements of the new EU IVDR 2017/746 involves a substantial regulatory framework for in vitro diagnostic (IVD) medical devices to ensure their safety and quality. The enhanced regulatory framework to speed up the market release includes, but is not limited to, additional scrutiny by a notified body, risk classification and conformity assessment, vigilance and market surveillance, and performance evaluation and performance studies…
