Upload your regulatory documents. Get EUDAMED-ready XML. Pay per device — volume discount built in.
350+ fields per device
CE certificates, DoCs, IFUs — Daiki reads your documents and extracts what EUDAMED needs.
Compliant XML, automatically
One element out of order and EUDAMED rejects the file. Daiki generates valid XML so you never touch a schema.
Deadlines that don't move
New devices: May 2026. Existing devices: November 2026. Unregistered devices lose EU market access.
30devices
1100+
ONE-TIME PROJECT FEE
€2,160
€72/device
Save 64%
PROJECT DELIVERABLES
AI document extraction
Reads CE certs, DoCs, IFUs
EUDAMED-ready XML
XSD-compliant, 17 namespaces
60+ validation rules
Checked before you upload
Bulk upload package
Ready for EUDAMED upload
MDR + IVDR support
Both regulations, all risk classes
Multi-NB tracking
Across all Notified Bodies
12 MONTHS ONGOING ACCESS INCLUDED
Certificate expiry alerts
Tracked before deadlines
Amendment workflow
Update docs, regenerate XML
Response parsing
See which devices passed or failed
EMDN update alerts
Flagged when codes change
Renew annually after 12 months.
Why Daiki
Upload and go
No need to learn EUDAMED's data model. Upload your CE certificates, DoCs, and IFUs. Daiki handles the rest.
Errors caught early
60+ business rules validated before you upload. No more rejected submissions and time lost debugging XML.
Schema handled for you
17 XML namespaces, strict element ordering, XSD v3.0.25 compliance. Daiki generates it. You never see the schema.
Amendments in seconds
Device changed? Upload the updated document. Daiki regenerates corrected XML. No starting from scratch.
MDR + IVDR in one tool
Both regulations, all risk classes, all device types. One upload flow, one XML package.
Built for international
EU or non-EU manufacturer. Same tool, same XML. Your AR uploads to EUDAMED on your behalf.
Frequently asked questions
How much does EUDAMED registration cost?
Daiki starts at €199 for a single device. The per-device cost decreases with volume — use the slider above to see your price. This covers AI extraction from your documents, validation, and a complete XML bulk upload package. EUDAMED itself has no submission fees.
Do I need software for EUDAMED?
You can enter data manually through EUDAMED's web interface, but for anything beyond a few devices the European Commission recommends XML bulk upload. This requires producing compliant XML files that match EUDAMED's data model. Daiki generates these from your existing regulatory documents.
What is the EUDAMED deadline?
New devices placed on the EU market must be registered from 28 May 2026. Existing devices already on the market must be registered by 28 November 2026. Without registration, devices cannot legally remain on the EU market.
What documents do I need?
The documents you already have: CE certificates, Declarations of Conformity, Instructions for Use, technical documentation, and risk assessments. Upload them and Daiki extracts the data.
Can non-EU manufacturers use Daiki?
Yes. Any manufacturer selling devices into the EU needs EUDAMED registration, regardless of location. Your Authorised Representative uploads the XML to EUDAMED on your behalf.
What happens after I pay?
Upload your documents. Daiki extracts the required fields, validates against 60+ EUDAMED business rules, and generates your XML bulk upload package. You get 12 months of access for amendments, certificate tracking, and response parsing. The XML files are yours to keep.
Do I need the annual access?
It's included. Your one-time fee covers 12 months of ongoing access — certificate renewals, device amendments, EMDN code changes, and EUDAMED response parsing. After 12 months you can renew annually.
Does Daiki submit directly to EUDAMED?
Daiki generates the XML package. You upload it via EUDAMED's bulk upload interface. Direct machine-to-machine submission is on our roadmap. Bulk upload is what the European Commission recommends for most manufacturers.