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EUDAMED is shifting from filing to active management

Here's what it changes for you

Free resources
to anchor your data governance

Get the "Eudamed, the Practical Guide"
EUDAMED compliance guidebook on a desk with a white background.

📗 White Paper — From Filing to Active Management

New: May 2026

EUDAMED has shifted the rules. Filing was a one-time act; what regulators now expect is continuous, demonstrable governance of regulatory data — across markets, across systems, across audits. Sixty pages by Jean-Philippe Joubert and Christophe Devins explain why your IT system cannot be the source of regulatory truth, what the new operating model looks like, and how to make compliance reusable instead of redone every quarter.

EUDAMED compliance guidebook for medical device manufacturers.

  • EUDAMED, de la déclaration au pilotage

    Ce que le passage à la conformité continue change pour les fabricants.

    Télécharger le livre blanc

  • EUDAMED, from filing to active management

    What the shift to continuous compliance means for manufacturers.

    Download the white paper

📘 Quick Guide — Master EUDAMED Compliance

Over 10.000 Download yet

Thirty pages of practical, no-jargon answers for medical device manufacturers preparing to register and maintain devices on EUDAMED. Built around real workflows: which actor declares what, when each module becomes mandatory, what each field actually expects, and where most teams hit walls on first submission. Designed to be opened beside your screen — not stored on a shelf.

EUDAMED Practical Guide cover with medical device professionals discussing compliance strategies.
  • French flag with three vertical stripes: blue on the left, white in the center, and red on the right.

    Préparez-vous en toute sérénité à EUDAMED

    Téléchargez notre guide complet pour comprendre les exigences et structurer vos prochaines étapes.

    Télécharger le Guide
  • The image shows the United Kingdom flag, also known as the Union Jack. It features a red cross on a white background, overlaid with red and white diagonal stripes on a blue field.

    Get Ready for EUDAMED with Clarity

    Download our comprehensive guide to better understand the requirements and define your next compliance steps.

    Download the Guide
  • The image shows the flag of Italy with three vertical stripes: green on the left, white in the middle, and red on the right.

    Affronta EUDAMED con sicurezza

    Scarica la guida completa per comprendere i requisiti e pianificare le prossime fasi del tuo progetto di conformità.

    Scarica la Guida
  • Flag of Germany featuring three horizontal stripes in black, red, and gold from top to bottom.

    EUDAMED sicher und strukturiert angehen

    Laden Sie unseren Leitfaden herunter, um die Anforderungen zu verstehen und Ihre nächsten Schritte gezielt zu planen.

    Leitfaden herunterladen

EUDAMED & GUDID regulatory alerts — delivered to your inbox

Receive concise updates on MDR/IVDR regulatory changes, EUDAMED registration deadlines, and GUDID compliance requirements. Built for RA/QA and regulatory affairs teams. No promotional content — only actionable changes.

🔒 Our Commitment
ACKOMAS will never share your data with anyone outside the company—for marketing or any other purpose. 100% GDPR compliant.

A smartphone displaying an email about an EU medical regulation update rests on a table next to eyeglasses, a printed regulatory timeline, and a cup of coffee.

  • Webinar replays & regulatory briefings

    Watch recorded sessions on EUDAMED registration, UDI structuring, and data governance

  • Deadline alerts & regulatory changes

    Be notified when EUDAMED deadlines, MDCG guidance, or submission rules change

  • Compliance guidance for your team

    Practical resources to prepare for audits, structure your UDI data, and manage multi-market registration