EUDAMED version 2.15.0: New features and corrections to the European database of medical devices
The European Commission has published the EUDAMED (European Database on Medical Devices) update notes for production version 2.15.0, which introduces new functionalities, improvements and corrections aimed at increasing the efficiency and reliability of the system.
Main highlights of the new version
The launch covered various areas of the EUDAMED platform, including device registration, certificate management and public portal functionalities.
Devices and UDI module
The concept of Master UDI-DI has been introduced for the registration of standard and custom-made contact lenses;
The device type "Orthopedic" has been removed from the list of special devices;
Problems related to search errors and bulk data downloads have been resolved.
Certificates and Notified Bodies Module
It is now possible to discard rejected or withdrawn applications and certificates;
Rejected applications cannot be submitted in the future.
Public Portal
Improvements to the search for devices with multiple criteria, making the selection of fields more intuitive;
Correction of errors that affected the visualization of manufacturers and devices.
Critical bug fixes
The problems solved include:
Errors in the mass download of devices and UDI-DI (duplication of results, XML export failures);
Problems deleting UDI-DI drafts and devices;
Inability of some users to complete actor registration or view associated data.
The complete list includes more than 50 relevant fixes reported by users.
Issues still to be resolved
The document identifies some known problems that remain active, such as:
Error messages when trying to view regulated devices connected to legacy devices;
Limitations on the registration of assemblies and systems by producers who are not manufacturers.
These issues will be addressed in future versions.
What does this mean for manufacturers?
The update reinforces the importance of:
Carefully validate the data submitted in the device register;
Periodically monitor the status of UDI-DI and certificates;
Be aware of future releases to ensure full compliance with Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
How Smart MDR can support
Smart MDR helps manufacturers, agents and importers through:
EUDAMED registration management;
Verification of UDI-DI and compliance data;
Strategy for submitting and resolving non-conformities;
Preparation for audits and inspections by the competent authorities
Contact us to ensure that your company takes advantage of EUDAMED's new features and complies with all regulatory obligations.
