Gap analysis is a crucial step for any company seeking EU EUDAMED compliance, as it serves to identify the differences between the company’s current operations and the new regulation. With realizing EUDAMED, manufacturers of medical devices will be required to comply with new regulations and requirements that will have an impact on their operations and […]
The European Commission (EC) has explained its first module on the actor’s registration for the new EUDAMED system under the new EU MDR 2017/745 and IVDR 2017/746. As already known, EUDAMED means European Data bank on Medical Devices. It’s a safe, web-based application that serves as a source for communicating information between the European Commission (EC) […]
EUDAMED is the Database on Medical Devices in the Europe. It will be a protected web application which will serves as a reference point for the flow of information between the European Commission (EC) and the national competent authorities. The regulations have been prepared, the EC is making Medical Devices’ EUDAMED ready, and it is […]