Especially based on the rationale of the MDR, a new registration system with EUDAMED has been introduced to ensure transparency for Medical Device Manufacturers and all sector stakeholders.
Medical Device Manufacturers;
- If EUDAMED is fully functional before the MDR application date, registration in EUDAMED must be completed within 18 months.
- Otherwise, it is expected that an announcement regarding the full functionality of the EUDAMED database will be published in the Official Journal of the European Union.
- Within 24 months after the publication date of the announcement, devices with MDD certification must be registered, or if there is a serious adverse event or field safety corrective action after the announcement, devices that are still placed on the market should be registered at the time of reporting the serious adverse event/field safety corrective action.
Note:
All Medical Devices with MDD certification must be registered in the EUDAMED database without Basic UDI-DI and UDI-DI only if a serious adverse event report and/or field safety corrective action report (with field safety notice) arises after the application date.
EUDAMED MODULES
- Actor Registration
- UDI/Device Registration
- Notified Bodies and Certificates
- Clinical Investigations and Performance Studies
- Vigilance and Post-Market Surveillance
- Market Surveillance