European Commission considering extending access to Eudamed to non-European authorities

Access to the European Database on Medical Devices (Eudamed) may be extended to non-European regulators in the interests of increasing the sharing of device safety information with the potential to create a new global data exchange standard for the industry.

The existing system with non-European regulators is based on reciprocity, where the Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR) provide the opportunity for non-European countries to exchange data with Eudamed to gain access to non-public data.

It is likely that countries that already take part in the National Competent Authority Report (NCAR) exchange program of the International Medical Device Regulators Forum (IMDRF) will be the first to gain access to Eudamed as the new data exchange system will be an extension of the existing NCAR system.

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Published on 22. February 2018 in News EU