As it prepares to meet new regulatory requirements in Europe, the medical device community is also following developments about the European Database for Medical Devices, or Eudamed. Eudamed is a publicly-accessible database that will be used to monitor the safety and performance of devices under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
Frequent interaction with Eudamed will be required for manufacturers, authorized representatives, importers, and sponsors, who must follow clear rules about what information and when to upload about their devices. If you are selling a medical device in Europe, it will be important to understand and comply with these requirements.
In this webinar, Ronald Boumans will discuss the role of Eudamed in MDR/IVDR compliance. You will learn:
- An overview of Eudamed’s functional specifications and the proposed transition plan
- When and how to exchange data with Eudamed as well as how this exchange will be monitored
- Who should access Eudamed and how this access will be granted
- How Eudamed will integrate with the Unique Device Identifier (UDI)
- A timeline of the Eudamed release schedule, which is targeted to begin in March 2020
- And much more
ABOUT THE PRESENTER
Ronald Boumans is Senior Regulatory Consultant at Emergo’s office in The Hague. He previously served as Inspector of Medical Technology at the Dutch Healthcare Inspectorate (IGJ), and his areas of expertise include European medical device legislation, Competent Authority supervision, Notified Body search, and CE Marking requirements.