EUDAMED Registration & Compliance
Get your devices into EUDAMED before 28 May 2026. No rejected submissions. No last-minute scrambles.
The Challenge
Common pain points that prevent medical device manufacturers from achieving EUDAMED compliance on time.
Data Integrity Chaos
120+ fields per device entry. Inconsistent GTINs, mismatched EMDN codes, and UDI data scattered across spreadsheets, ERPs, and label files. Most internal teams are not equipped to cleanse and structure this volume of data to EUDAMED's validation requirements.
Actor & Supply Chain Confusion
Manufacturers assume their Authorised Representative or Notified Body will handle registration. They will not. The manufacturer is the sole legal entity responsible for UDI data integrity and submission. Meanwhile, importers need their own SRNs, and if your EU AR linkage is wrong, your entire submission is blocked.
Deadline Exposure
New MDR/IVDR devices must be registered before market placement from 28 May 2026. Legacy devices already on the EU market must be registered by 27 November 2026. Certificates issued before 28 May 2026 must be uploaded by 28 May 2027. Miss any of these and your devices are no longer legally authorised for sale in the European Union.
The VigilaMed Solution
End-to-End EUDAMED Registration
We handle every phase of EUDAMED compliance — from Actor Registration and SRN verification through to UDI/Device data submission and post-registration maintenance. Our methodology is built from hands-on project delivery for US and EU manufacturers navigating the full EUDAMED registration lifecycle under real deadline pressure.
Manufacturing-First Methodology: We do not just prepare your data — we structure it so your EUDAMED entries align with your technical documentation, labels, certificates, and declarations of conformity. One consistent data architecture from label to database.
What You Get
Tangible deliverables that deliver immediate value and long-term EUDAMED compliance.
- EUDAMED Readiness Gap Assessment (Red/Amber/Green report)
- Actor Registration & SRN Verification (Manufacturer, EU AR, Importers)
- Basic UDI-DI Grouping & Structuring
- UDI-DI Data Cleansing & Validation (GTIN verification, EMDN classification)
- Full UDI/Device Module Data Submission (manual or XML bulk upload)
- Label-to-Database Consistency Audit
- EU Importer Obligation Management (MDR Article 13 compliance)
- Notified Body Certificate Linkage Verification
- Post-Registration Maintenance & Update SOP
- EUDAMED Compliance Project Plan & Deadline Tracker
How It Works
Phase 1 - Discovery & Data Audit
We audit your existing UDI data, label files, GTIN records, and technical documentation against EUDAMED's 120+ field requirements.
Gap report within 5 business days.
We handle every step securely and properly before the deadline.
EUDAMED MANDATORY DEADLINES // YOUR COMPLIANCE WINDOW
28 May 2026
All new MDR/IVDR devices must be registered in EUDAMED before being placed on the EU market. No registration = no market access.
27 November 2026
All legacy devices and devices placed on the market before 28 May 2026 must be retrospectively registered. This covers the bulk of most manufacturers' portfolios.
28 May 2027
All certificates issued before 28 May 2026 must be uploaded by Notified Bodies. Manufacturers must ensure their device data links correctly to these certificates.
Commission Decision (EU) 2025/2371 confirmed these deadlines. The era of voluntary EUDAMED is over.