The Role of Eudamed under the MDR and IVDR

This white paper takes a deep-drive into the functionality and role of the new Eudamed.
Questions? Request more information from our specialists
CONTACT USThe 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.
Related services for Europe:
- CE Mark Certification for Medical Devices
- Clinical Evaluation Reports (CER) for Medical Devices in Europe
- EU IVDR Gap Assessment and CE Transition for IVD Companies
- EU MDR compliance consulting for cosmetic and aesthetic products
- EU Medical Device Vigilance Reporting in Europe
- EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
- European Authorized Representative for Clinical Trials
- European Authorized Representative for Medical Device Companies
- European MDR 2017/745 Gap Assessment and CE Transition Strategy
- European Union Medical Device Classification
- In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
- IVD Certification and Registration to Obtain CE Marking in Europe
- Medical Device and IVD Emergency Use Routes in Europe
- Medical Device Technical File and Design Dossier for EU CE Marking
- Switzerland Representative for Medical Device Companies
- UKRP and Brexit consulting for medical device companies