The in-vitro diagnostics regulation (IVDR): From oversight to overhead Author: Matthias Havenaar WHITEPAPER SEPTEMBER 2018castoredc.com 2 IVDR: From oversight to overhead The increasing expectation for early and accurate disease diagnosis along with the growing possibilities in personalized medicine has fueled the demand for in-vitro diagnostic medical devices (IVDs). These devices include laboratory or point-of-care devices, kits and reagents as well as other accessories, which are used to perform diagnostic tests on human samples. The global IVD market is estimated EUR 58 billion globally and is expected to reach EUR 75 billion by 2023, with Europe holding around one-third of this market. Source: Lab on a Chip In recent months, many articles have been published on the coming Medi

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