To bring a medical device to market in the European Union, there are a number of complex regulatory-related tasks that will need attention. Medical device registration and Unique Device Identification (UDI) are two major areas with specific requirements. Industry activity has been underway for some time in preparation for the launch of the EUDAMED database in May 2022.
EUDAMED is the web-based portal implemented by the European Commission to serve as a centralized database for economic operators (medical device manufacturers world-wide, designated representatives and system/procedure pack providers) for the registration and required EU regulatory information submission. The existing three directives for the European Union--Medical Devices (MDD), Active Implantable (AIMDD) and In Vitro Diagnostics (IVDD) have been replaced by 2 regulations, the Medical Devices Regulation (MDR) 2017/745 and the In Vitro Diagnostics Regulation (IVDR) 2017/746. Unique Device Identification (UDI) database requirements are being implemented by a number of global health regulators to improve the safety of patients and facilitate product modernization.
Regulatory compliance teams will benefit from experienced help with the nuances of UDI requirements and product data management. The UDI/Device Registration Module is on-track to open to voluntary submissions Fall 2021.
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Contact Reed Tech for solutions and services for medical device UDI requirements for EUDAMED and other global health authorities.
“Reed Tech has good knowledge about the UDI demands for different markets around the world.”
– Regulatory Compliance Manager, Dentsply Sirona