Current Knowledge and State of the Art of Public Disclosure for Medical Devices
11:25 AM - 11:55 AM
Public disclosure and data sharing have become mainstream in the pharmaceutical industry. However, these concepts are still unfamiliar to the medical technology industry. The EU MDR 2017/745 mandates increased clinical data transparency in the EU. This entails public disclosure of information, data, and documents through the European Database for Medical Devices (Eudamed). This presentation provides the current knowledge on the Eudamed and the state of the art of transparency and public disclosure of medical devices almost a year after the application of the MDR.