The European Database on Medical Devices (EUDAMED) is a central pillar of the EU Medical Device Regulation (EU MDR), designed to enhance transparency, traceability, and regulatory oversight across the medical device lifecycle.
While EUDAMED has been rolled out in phases, May 2026 marks a critical milestone, with several core modules becoming mandatory. For manufacturers and other economic operators, this represents a shift from optional use to fully integrated regulatory obligations.
In this blog, we explain what is changing, which modules are affected, and what companies should do now to ensure compliance.
What is EUDAMED?
EUDAMED is a centralised IT system developed by the European Commission to support the implementation of the EU MDR. It connects manufacturers, notified bodies, competent authorities, and other economic operators through a single platform.
Its purpose is to:
- Improve transparency of medical devices on the EU market.
- Ensure traceability across the supply chain.
- Strengthen post-market surveillance and vigilance.
- Facilitate information sharing between authorities and stakeholders.
Mandatory Modules from May 2026
EUDAMED is composed of multiple interconnected modules. Following its phased implementation, the European Commission confirmed that key modules become mandatory from May 2026.
These include:
- Actor Registration Module
This module requires economic operators (manufacturers, authorised representatives, and importers) to register in EUDAMED in order to obtain a Single Registration Number (SRN).
The SRN is essential for:
- Identifying companies within the EU regulatory system.
- Interacting with authorities and notified bodies.
- Completing other EUDAMED registrations.
Key takeaway: if not already completed, companies must ensure they are registered and that their SRN is active and correctly linked to all relevant entities.
- UDI/Device Registration Module
This module enables the registration of devices using the Unique Device Identification (UDI) system.
Manufacturers must upload:
- Device information.
- Basic UDI-DI and UDI-DI data.
- Device classification and intended use.
Key takeaway: UDI data must be accurate, consistent, and aligned with technical documentation, as discrepancies may trigger regulatory scrutiny.
- Notified Bodies and Certificates Module
This module provides information on:
- Notified Bodies
- Issued certificates
- Scope of designation
It improves visibility of certification status across the EU.
Key takeaway: manufacturers should verify that their certificates are correctly recorded and up to date, as this information is accessible to authorities.
- Market Surveillance Module
This module allows competent authorities to:
- Monitor devices on the market.
- Record inspections and compliance checks.
- Track corrective actions.
For manufacturers, this increases regulatory visibility and reinforces the importance of maintaining compliance throughout the product lifecycle.
Key takeaway: companies should ensure that internal processes (e.g., PMS, complaint handling) are robust and aligned with regulatory expectations.
What This Means for Manufacturers
From May 2026, EUDAMED is no longer something to prepare for—it is part of day-to-day regulatory operations.
Manufacturers should expect:
- Greater transparency of their products and certifications
- Increased scrutiny from competent authorities
- Stronger links between documentation, registration, and real-world data
Importantly, inconsistencies between EUDAMED entries and technical documentation may lead to compliance issues.
Practical Steps to Ensure Compliance
To remain compliant and avoid disruptions, companies should take a proactive approach:
- Confirm Actor Registration and verify SRN details.
- Review device registrations for accuracy and completeness.
- Align UDI data with technical documentation.
- Check certificate visibility within EUDAMED.
- Strengthen PMS and vigilance processes.
- Train internal teams involved in regulatory and data management.
Conclusion
The transition to mandatory EUDAMED modules marks a significant step in the full implementation of the EU MDR.
For manufacturers, the focus must shift from preparation to execution—ensuring that all data is accurate, systems are aligned, and regulatory processes are robust.
A well-managed EUDAMED strategy not only supports compliance but also strengthens transparency, traceability, and trust in the EU medical device market.