The new European medical device database, known as Eudamed, was originally scheduled to launch in May 2020, but the pandemic caused its implementation to be delayed two years, until May 26, 2022. However, that does not mean that compliance considerations are on hold.
Companies will still have to meet the May 2021 deadline for the Medical Device Regulation (EU MDR), which was also pushed back a year due to COVID-19 in order to prevent the disruption of medical supplies. The new regulations on medical devices (MDR) and on in vitro diagnostic medical devices (IVDR) establish a much wider Eudamed database than the existing one under the current European Directives.
Some modules of Eudamed will be made available to users before the official Eudamed date of application in May 2022, making it possible for economic operators (EO) to start using Eudamed before that date. This will help companies to prepare for full implementation and will also help authorities smooth out unforeseen issues before the date of application.
The new database will have several advantages over the existing Eudamed2, which was introduced in 2011. That database, which acts as a central repository for market surveillance information, is only accessible to the European Commission and the national competent authorities. Since it can’t be accessed by other groups, medical device companies can’t verify their data or check how that data is represented.
Eudamed consists of seven databases working together, and part of Eudamed will be publicly accessible. While the European Commission is responsible for Eudamed, users will all be responsible for their own content. There will be an extensive amount of information collected and transmitted electronically as well as a mandate to use unique device identification (UDI). The challenge of how to keep track of devices placed on Europe’s borderless but sovereign markets is addressed by a combination of mandatory inputs by Notified Bodies, EOs, and member states into Eudamed.
Eudamed will be part of a system of several databases, closely interacting with each other:
- Economic operators
- Certificates (issued, suspended, withdrawn, etc.)
- Clinical Investigations
- Vigilance (incident reports and Field Safety Corrective Actions, but also Periodic Safety Update Reports)
- Market Surveillance
Closely linked to Eudamed are the databases with nomenclature for medical devices and for incident reporting. Lastly, the database with Notified Body information, NANDO, will be related to Eudamed although it will remain independent and controlled by the European Commission.
The delay in Eudamed implementation has been viewed by many in the medical device industry as a positive. Companies with MDR Eudamed projects in the works have gained valuable time to prepare for the changes coming in regulatory compliance requirements; however, there is no reason for companies to slow down or postpone projects, especially since there is a tendency to underestimate project complexity. The consensus seems to be that manufacturers should keep moving forward in gaining expertise and preparing their submissions in advance of the May 2022 Eudamed launch.
If you would like to learn more about Eudamed as well as EU MDR and IDVR changes, please contact the European regulatory experts here at MEDIcept.
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For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.