The European Database for Medical Devices, or Eudamed, is a major part of Europe's new medical device and IVD regulations. Eudamed is a database that will be used to monitor the safety and performance of devices under the Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). The medical device community is anxious to learn how they will be required to interact with Eudamed and how information about their device performance will be shared.
In this white paper, we explore the purpose and function of Eudamed, and how medical device companies will access it. You will learn:
- Who will have access to Eudamed and their roles
- What information is available to the public
- When, what, and how you can expect to upload data
- The role of Eudamed in the UDI system
- Different sections within the database
- When Eudamed is expected to launch
We discuss all this and more in this 14-page white paper.