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EUDAMED 2026: Compliance becomes mandatory. Are you ready?
Medical device manufacturers: If your medical devices are not registered in EUDAMED before May 28, 2026, you will no longer be able to legally market them in the European Union.
Even if you already have CE marking or are already selling in Europe, you must register your medical device with UDI-DI and product data to EUDAMED.
Your products may no longer be legally placed on the EU market
You risk audits, penalties, and even product withdrawals
EUDAMED (European Database on Medical Devices) is the official EU platform for regulatory compliance. It ensures transparency, traceability, and patient safety. Without registration →
Why It Matters?
Understand the EUDAMED process
We walk you through the steps to register your company, obtain your SRN, and prepare for UDI-DI submissions.
Know what data to prepare
We explain exactly which product details, GTINs, and documentation you’ll need for a successful registration.
Get practical advice tailored to your situation
Whether you’re registering your first product or updating existing entries, we provide advice based on your regulatory context and product class.
Avoid common mistakes
With our guidance, you can reduce the risk of delays or rejections due to formatting errors or missing data.
Don’t Wait for the Last Minute
The clock is ticking. Contact us now and stay ahead of the deadline.
What awaits you WITHOUT EUDAMED registration
❌ Ban on placing products on the EU market — Your products become illegal
❌ Stricter regulatory audits — Controls by ANSM and national authorities
❌ Heavy financial penalties — Administrative fines
❌ Product withdrawals — Forced recalls, destruction of stock
❌ Loss of credibility — Distributors and agents abandon you
Source officielle : Commission Européenne — EUDAMED Mandatory Compliance 2026Source officielle
OUR SERVICES
EUDAMED Account and SRN Support
We guide you through obtaining your EUDAMED SRN from the ANSM
We create and configure your EUDAMED account with you
We train you on the interface (or manage everything for you, depending on your chosen plan)
01
Automatic extraction and structuring of your data.
We scan your sources: website, catalogs, technical data sheets, IFU notices, CE certificates.
We extract regulatory data from your product catalogs.
We categorize according to EMDN and the MDR/IVDR taxonomy.
We verify the consistency and compliance of each attribute.
We deduplicate information.
02
Génération des UDI-DI, Basic UDI-DI, Master UDI-DI, Packaging UDI
Création automatique des identifiants UD, BUDI, MUDI
Formatage conforme GS1 (DataMatrix, Code 128, HRI/AIDC)
Validation des règles métier EUDAMED et MDCG selon vos dispositifs médicaux
03
Automatic multilingual translation
Generation of regulatory content in French, English, German, Spanish, Italian, Portuguese, etc.
Standardized templates compliant with EUDAMED language requirements
Terminological consistency (MDR/IVDR glossaries)
04
Automatic publication in EUDAMED
Data transmission to Playground beforehand
Real-time error handling and corrections
Continuous updates (new batches, product modifications)
30x faster than manual entry
05
Audit Trail and Documentation
Complete traceability of every action (who, when, what)
Automatic version archiving
Generation of declarations of conformity
Ready for your audits by ANSM, notified bodies, clients, and distributors