European Commission Confirms Functionality of Key EUDAMED Electronic Systems: What This Means for Medical Device Manufacturers
The European Commission has published Commission Decision (EU) 2025/2371, officially confirming that four core electronic systems within EUDAMED are now fully functional and meet all required functional specifications.
This milestone triggers the start of the mandatory transition periods for several MDR/IVDR electronic obligations, as defined in Articles 123(3)(d)–(ec) MDR and 113(3)(f)–(fd) IVDR.
The Decision follows an independent audit (June 2025), which validated that the completed electronic systems operate according to the functional specifications published in version 7.2.
Electronic systems confirmed as functional
According to Article 1 of the Decision, the following EUDAMED modules are now validated and ready for mandatory use:
Economic Operators Registration System
UDI Database & Device Registration System
Notified Bodies & Certificates System
Market Surveillance System
These systems form the backbone of EUDAMED and are crucial for device traceability, regulatory oversight, and post-market safety.
Impact on Manufacturers
1. Mandatory use of these EUDAMED modules will begin
With the systems confirmed functional, the legal transition periods start immediately, meaning manufacturers must prepare for mandatory use of:
UDI and device registration
Economic operator registration
Certificate listings
Market surveillance reporting
2. Increased regulatory visibility and traceability
Manufacturers will face stricter obligations related to device registration, UDI, and certificate transparency. Competent authorities and notified bodies will have direct access to device, operator, and certificate data.
3. Alignment of internal systems becomes urgent
Companies must ensure internal UDI databases, ERP systems, and regulatory processes are aligned with the structured EUDAMED requirements.
4. More scrutiny for legacy devices
Once mandatory, EUDAMED will reinforce traceability obligations, affecting both MDR-certified devices and extended transitional (“legacy”) devices.
5. Strengthening of post-market responsibilities
With the Market Surveillance module validated, manufacturers should expect increased oversight, more consistent enforcement, and faster authority response times.
This Commission Decision marks a major step toward full EUDAMED activation, significantly impacting all manufacturers placing devices on the EU market. Smart MDR will continue monitoring upcoming guidance and implementation timelines to support manufacturers through this transition.
The full Commission Decision is available for download below.
