Structure of the EUDAMED ecosystem
EUDAMED is entering its final phase of development, marking an important transition point for the European regulatory landscape. Once fully functional, the database will serve as the central infrastructure for device registration, vigilance reporting and regulatory collaboration under the MDR.
EUDAMED consists of six interconnected modules covering actor registration, device identification, notified bodies and certificates, clinical investigations, vigilance and market surveillance. Each module is designed to increase transparency and strengthen regulatory coordination among Member States.
New obligations for manufacturers
Upon full activation, manufacturers must register their devices in the UDI database, submit detailed technical and administrative information and maintain accuracy throughout the device lifecycle. This includes ensuring that UDI-DI data reflects the device’s intended purpose, classification, conformity assessment route and applicable certificates.
Responsibilities of Importers and Authorised Representatives
Importers and authorised representatives must verify that devices placed on the market are correctly registered and that the manufacturer’s information is complete. They will also be responsible for ensuring that incident reports and FSCAs are submitted in accordance with Articles 87–90 MDR.
Centralised vigilance reporting
The Vigilance module will replace fragmented national systems, providing a unified interface for reporting serious incidents, trend analyses and field safety corrective actions. This centralisation aims to improve response times and support mutual recognition of assessments across Member States.
Enhanced market surveillance coordination
The Market Surveillance module will enable authorities to share information on inspections, non-compliances, restrictions and corrective measures. This supports harmonised enforcement across the EU and reduces duplication of regulatory actions.
Preparing for implementation
Economic operators must assess their readiness by reviewing UDI assignment processes, device master data, PMS procedures and IT infrastructure. Many will need to update quality management systems to accommodate EUDAMED-specific data governance requirements.
Conclusion
The full deployment of EUDAMED represents a transformational moment for the EU medical device framework. Although the transition requires substantial preparation, it promises increased transparency, strengthened oversight and more efficient regulatory collaboration across the Union.