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As the EUDAMED compliance deadline draws near, regulatory affairs teams across the medical device sector are under growing pressure to ensure their organizations are ready. With significant regulatory changes ahead, it’s essential to organize UDI data, align with evolving EU requirements, and minimize the risk of last-minute challenges that could impact compliance.

The European Database on Medical Devices (EUDAMED) is a cornerstone of both the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). Its main objectives are to strengthen transparency, traceability, and patient safety across the European medical device market. As a result, manufacturers must meet specific deadlines for registering both new and existing devices in EUDAMED.

• Newly Launched Devices: All new medical devices and IVDs placed on the EU market under MDR or IVDR after mandatory EUDAMED use begins (expected March 2026) must meet UDI requirements and be registered in EUDAMED before they are marketed.
  
• Key Requirement: Manufacturers must assign a Basic UDI-DI and enter
  device data into EUDAMED before placing the product on the EU market, once the relevant modules are mandatory.
  

• All Devices: Devices already placed on the market before the EUDAMED
  application dates, that are still placed on EU market, fall under transitional provisions. These products must also be registered in EUDAMED (expected September 2026).
  
• Legacy Devices placed on EU market under MDD/IVDD/AIMDD are
  especially falling into that category.
  
• Key Requirement: Manufacturers need to update UDI data, for among others, legacy devices and complete their registration in EUDAMED within the 12-month transition period from EUDAMED applicablity date, this is expected to start in September 2026.
  

• Q1 2026: Mandatory use of the core EUDAMED modules (Actor, UDI Devices, Notified Bodies & Certificates, Market Surveillance) is expected to begin. Newly placed devices registrations become mandatory.
  
• Q3 2026: Mandatory use of the core EUDAMED modules with special regard to all devices placed on the market prior to EUDAMED applicability becoming mandatory to register. Vigilance module go-live and mandatory usage.
  

Meeting these requirements will require careful planning and attention to detail, especially for UDI assignment, Basic UDI-DI management, and accurate data submissions.

• Audit Your Data: Review your current UDI data for completeness and
  consistency.
  
• Optimize Processes: Consider digital tools and internal process reviews to support accurate data validation, submission, and monitoring.
  
• Stay Informed: Regularly check updates from the European Commission, EU UDI Helpdesk, and EUDAMED guidance documents for the latest requirements and interpretations.
  

By preparing now, manufacturers can avoid last-minute compliance issues and help ensure uninterrupted market access for their devices. Early action on data and processes is the best way to approach the upcoming EUDAMED deadline with confidence.

• https://health.ec.europa.eu/document/download/04ce2012-97df-4dd0-8a39-d4f6993b9e16_en?
  
• https://health.ec.europa.eu/medical-devices-eudamed/overview_en