EUDAMED in Practice: Implementing (EU) MDR Data Requirements

Interested participants from other time zones are welcome to contact us regarding the training at [email protected].

As part of the European Union’s effort to enhance transparency, traceability, and post-market surveillance of medical devices the European Database on Medical Devices (EUDAMED) plays a central role in the implementation of Regulation (EU) 2017/745 (MDR). 

For manufacturers, importers, authorized representatives and notified bodies, understanding and correctly implementing EUDAMED data requirements is critical to maintaining compliance within the European market. However, the complexity of modules, data fields and UDI-related requirements often creates significant challenges in day-to-day operations.

The “EUDAMED in Practice: Implementing (EU) MDR Data Requirements” training provides participants with the essential knowledge and practical guidance to navigate EUDAMED efficiently and confidently. The course focuses on how to interpret MDR requirements, prepare compliant data submissions and manage your organization’s EUDAMED presence effectively ensuring accuracy, consistency and regulatory readiness. 

Participants will gain insights into the status and phased implementation of EUDAMED modules, learn how to fulfill registration and reporting obligations, and explore strategies for integrating EUDAMED-related processes into their existing Quality Management Systems (QMS). Special emphasis will be placed on UDI registration, actor registration and future vigilance reporting, which are key to achieving and maintaining compliance in the EU market. 

Key Topics Covered

• Overview of EUDAMED’s architecture, modules and interconnections:
o Actor Data
o UDI/Device Data
o Notified Bodies and Certificates
o Clinical Investigations/Performance Studies
o Vigilance and PMS
o Market Surveillance
• Updates on EUDAMED implementation timelines and module use
• Live Demonstration – Insights and Pitfalls:
o Actor registration process, acquiring SRN(s) and user management
o Entering and managing UDI and device data
o SS(C)P connection
o Outlook on vigilance reporting and field safety corrective actions
• Alignment with (EU) MDR articles and deadlines
• Practical considerations for SMEs, system integration and data governance
• Impact on internal process alignment and audit readiness

Key Benefits

By the end of this training, participants will:

• Understand the regulatory purpose and scope of EUDAMED under (EU) MDR
• Know how to register actors and devices and comply with data submission requirements
• Be able to navigate and use EUDAMED modules effectively
• Learn how to integrate EUDAMED tasks into existing regulatory and quality systems
• Be better prepared for Notified Body interactions and competent authority oversight

Target Audience: Regulatory Affairs professionals, Quality and Compliance Managers, Manufacturers, Authorized Representatives and Importers, Clinical Affairs and Vigilance Teams, anyone involved in EUDAMED data entry or governance.

Certificate: Participants receive a Certificate of Attendance of DQS MED GmbH

Trainer: Is a highly qualified regulatory expert from DQS MED, a leading Notified Body with deep expertise in conformity assessment under EU MDR.