Expertise: Medical Device 43 results
CE marking is mandatory for marketing medical devices and in vitro diagnostics (IVDs) in the European single market, comprising all European Union (EU) member states and European Economic Area (EEA) countries. With the introduction of the EU Medical Devices Regulation...
On September 29, 2023, the U.S. Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs).
Medical Device
5 Stages of Medical Device Development
Medical device development must address some unique challenges that have grown over the last decade due to increasing medical device complexity, a more complex regulatory framework catching up with the industry, and an established and variable standard clinical practice to...
Medical Device
OCT Medical Devices EU
Medical devices are ubiquitous — from thermometers, bandages, and dental floss to blood glucose meters, hearing aids, and complex implantables such as pacemakers. The latest cutting-edge examples even extend to apps on tablets and PCs that physicians use to help...
Over the past decade, the development of digital medicines has been steadily gaining momentum, with real-world data demonstrating that these approaches can help improve patient lives. The COVID-19 pandemic further propelled the digital medicines industry forward by shining a light...
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...