Katharina Keutgen

Unique Device Identification (UDI) in the EU

By Katharina Keutgen October 24, 2024 Leave a comment

With the UDI system, the EU has introduced an obligation to identify and register medical devices that goes far beyond what is still required under the MDD. The Medical Device Regulation (MDR) even requires a UDI for standalone software. Read about what you need to prepare for here. 1. Objectives of the UDI system The…

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EUDAMED: European Database on Medical Devices

By Katharina Keutgen August 30, 2023 Leave a comment

EUDAMED is the European database for medical devices. However, it is not only used to manage medical devices. The Medical Device Regulation (MDR) relies on EUDAMED and determines which requirements must be stored in this database. These regulations affect the work of manufacturers and also the work of authorities and notified bodies. 1. Which purpose…

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