EUDAMED

EUDAMED is the centralized European database required under Article 33 of EU MDR 2017/745 and EU IVDR 2017/746. It aims to improve transparency, facilitate market surveillance, and enhance patient safety across the European Union.

Six core modules:

1. Actor registration module:
- Manufacturers, authorized representatives, importers, distributors
- All economic operators must register before placing devices on market
- Single Registration Number (SRN) issued to each actor
- Mandatory for both EU and non-EU operators

2. UDI and device registration module:
- Basic UDI-DI (Unique Device Identifier - Device Identifier) required
- Device information including classification, intended purpose
- Instructions for use and labeling
- Economic operators associated with device

3. Notified Bodies and certificates module:
- Notified Body information and designations
- Certificates issued for conformity assessment
- Certificate status tracking (valid, suspended, withdrawn)
- Public access to certificate information

4. Clinical investigations and performance studies:
- Registration of clinical trials (EU MDR)
- Performance studies (IVDR)
- Coordination between member states
- Serious adverse event reporting from studies

5. Vigilance and post-market surveillance:
- Incident reporting system
- Field safety corrective actions (FSCA)
- Periodic Safety Update Reports (PSUR)
- Trend reporting
- Integration with national competent authorities

6. Market surveillance:
- Coordination between EU member states
- Joint audits and inspections
- Information sharing on non-compliant devices
- Enhanced enforcement capabilities

Implementation timeline:
- 2020: Actor registration available
- 2021: UDI/device registration launched
- 2022: Certificates and Notified Bodies module
- 2023-2024: Remaining modules phased in
- Ongoing: System improvements and full functionality

Key requirements:

For manufacturers:
- Register company before CE marking
- Obtain SRN (Single Registration Number)
- Register all devices with UDI-DI
- Upload technical documentation summaries
- Report incidents and field safety corrective actions
- Submit PSURs for implantable and Class III devices

For authorized representatives:
- Separate actor registration required
- Must be linked to manufacturer in system
- Access to manufacturer's device information

Public access features:
- Device information and intended purpose
- Certificates and Notified Bodies
- Clinical investigation summaries
- Some vigilance information
- Helps healthcare professionals and patients make informed decisions

Data protection:
- Commercial confidential information protected
- Personal data handled per GDPR
- Controlled access levels for different user types

Integration with national systems:
- Member states competent authorities have full access
- Replaces previous national databases
- Enables EU-wide coordination

Challenges and delays:
- Technical complexity led to phased rollout
- Initial delays in full functionality
- Learning curve for economic operators
- System performance improvements ongoing

EUDAMED represents a major step toward harmonization and transparency in EU medical device regulation, though full implementation continues to evolve.