In vitro diagnostics (IVDs) have become a cornerstone of modern medicine, and rising demand for these critical medical devices has driven rapid market growth. Since 2021, hospitals and laboratories have demonstrated an increasing preference for point-of-care testing devices to get...
Charles Chrisawn
Significant risk studies of medical devices require an investigational device exemption (IDE), which allows the device to be used in a clinical study to collect data on its safety and effectiveness.1 Often, device developers wonder whether—and how—the cost of those...
An investigational device exemption (IDE) allows an investigational device to be used in a clinical study to collect data on its safety and effectiveness.1 This exemption applies to the conduct of trials necessary for developing new medical devices. Most often,...
Development of liquid biopsies for early cancer detection requires careful planning. Understanding the regulatory environment and the challenges of conducting the studies needed for approval is integral to success. Here, we review the regulatory pathways for in vitro diagnostics (IVDs)...
Cancer is the leading cause of death worldwide, accounting for nearly one in every six deaths. According to a recent paper, an estimated 15% of cancer-related deaths could be avoided by early disease detection.1 However, there are currently very few...
Molecular diagnostics can provide a more precise and scientifically sound basis for the practice of medicine. However, barriers to their adoption may increase the risk for developers and delay the practice of precision medicine. With the recent evolution of regulations...
Healthcare payers, regulators, and physicians focus on clinical utility when evaluating molecular diagnostics tests. Clinical validation — establishing that the test can make a diagnosis or predict clinical outcomes — may not be enough to garner acceptance. This point is...
Medical Device
FAQs: In Vitro Diagnostic Medical Device Regulation
On May 26, 2017, the EU Regulation 2017/746 of the European Parliament and the Council on in vitro diagnostic medical devices (IVDR) became active under the EU Regulation on Medical Devices (MDR). Recertification by May 26, 2022, became required for...