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 governing investigational diagnostics, it has become vitally important for diagnostics developers to understand how to…
Charles Chrisawn
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 crucial, because failure to gain acceptance deprives patients of much-needed health benefits and results in…
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 all previously approved products. The IVDR will replace the EU’s current Directive on in vitro…