With the implementation of UDI in the EU following the roll out of the Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR), the European Database for Medical Devices (EUDAMED) has been created in anticipation. It has now been suggested that this database will be extended and set the global data exchange standard.
Currently when accessing EUDAMED European Authorities have full access to the data while those outside only have public or limited access. The European Commission is considering extending the access to boost sharing of the device safety information with the suggestion that this can set the standard for global data exchange in the industry.
This extended access will be rolled out, the European Commission is thought likely to choose those already taking part in the NCAR exchange programme. The data exchange would be an extension to the NCAR system.
This seems a very ambitious project and we imagine it will take some time to coordinate. We suspect that it will require other UDI systems to become compatible with EUDAMED and that they will be involved in its further development.
If you would like some assistance with managing your medical devices and their UDI data please reach out to our experts here at Instem. This can be done via our main contact number +44 1785 825653 or email us on [email protected].