Legacy device deadline: November 28, 2026

Your EUDAMED data
isn't ready.

Every medical device sold in the EU must be registered in EUDAMED. Your ERP exports don't match the 95+ field schema. Your spreadsheets have gaps. The deadline is real. EUDAMate transforms your messy data into validated, submission-ready XML.

Get your free readiness reportSee how it works
55+ EUDAMED fields mappedMDR, IVDR, & Legacy directivesDTX-compliant XML output

Time until legacy deadline

227
days
:
05
hrs
:
00
min

All MDD/AIMDD/IVDD devices must be registered in EUDAMED

The problem nobody's solving

EUDAMED expects structured, validated data in a specific XML schema. Your product data lives in ERP systems, Excel files, and paper archives — none of which speak EUDAMED. That gap is where registrations fail.

95
fields per device in EUDAMED
Most ERPs export 10-15
8,454
EMDN codes to classify into
Manual lookup takes hours per device
50+
validation rules before submission
One error = full rejection

From messy spreadsheet to EUDAMED-ready XML

Two ways to work with us: a done-with-you Data Prep Sprint, or self-serve through our upload wizard. Same pipeline, same quality.

Step 1

Upload your data

Drop your Excel, CSV, or ERP export. Any column names, any language. We handle the mess.

Step 2

AI maps & classifies

Columns mapped to EUDAMED fields. EMDN codes assigned. Every suggestion confidence-scored: Green, Yellow, or Red.

Step 3

You review & decide

Glass-box AI — you see every suggestion and its confidence. Override anything with a logged reason. Co-pilot, not autopilot.

Step 4

Download & submit

Get DTX-compliant XML, clean CSV, and your Registration Decision Record (RDR) for QMS compliance.

Glass-box AI — nothing hidden

Every AI suggestion is confidence-scored. You see exactly what the AI is sure about, what needs your expert eye, and what requires manual entry.

Green — High Confidence

AI is 90%+ confident. Auto-approved by default. One click to approve all Green fields at once.

Basic UDI-DI
04046719012345
Yellow — Needs Review

AI has a suggestion but confidence is moderate. Shows alternatives. Your expert judgment decides.

EMDN Code
P090101 ?
Alt: P090102, P090199
Red — Manual Entry

Data missing or too ambiguous. You enter the value. Every entry is logged with a reason for your audit trail.

Certificate Reference
Not found in source data
Limited availability

Data Prep Sprint

Send us your data. We run it through our pipeline, an expert reviews every Yellow and Red field, and you get submission-ready XML + your RDR audit document. Done-with-you, not done-for-you — you own every decision.

We handle column mapping, EMDN classification, and validation
Expert reviews all AI suggestions below Green confidence
You approve or override — every decision logged in your RDR
Deliverable: XML + CSV + RDR PDF for your QMS binder
Typical turnaround: 3-5 business days
Registration Decision Record — signed PDF per device for your QMS
Get your free readiness report
Starting at
€2,500
for up to 10 devices
11-50 devices+€200/dev
51-100 devices+€175/dev
100+ devicesCustom quote
Example pricing
10 devices€2,500
30 devices€6,500
50 devices€10,500
100 devices€19,250

May 2026 deadline? Priority processing available (+25%)

How EUDAMate compares

EUDAMate is the upstream data preparation layer — it feeds into your existing tools, not replaces them.

EUDAMate SprintManual prepRA consultantUpload tools*
Handles messy source data✓✗✓✗
EMDN auto-classification✓✗✗✗
50+ validation rules✓✗~~
Audit trail (RDR)✓✗✗✗
DTX-compliant XML✓✗✗✓
Cost per 100 devices~€19K~€50K+~€100K+€5K+
Time for 100 devices1-2 weeks3-6 months1-3 monthsN/A†

* Upload tools (tracekey, EudaMed+) require pre-cleaned data. EUDAMate prepares data for these tools.
† Upload tools can't process messy source data — they require the preparation EUDAMate provides.

ISO 13485-aligned

Controlled vocabulary, append-only audit trail

MDR & IVDR ready

Plus all legacy directives: MDD, AIMDD, IVDD

EUDAMED DTX schema

XML output matches the official bulk upload format

GDPR compliant

Data processed in EU. No device data stored after delivery.

Frequently asked questions

Do you submit to EUDAMED on our behalf?
No. EUDAMate prepares your data — column mapping, EMDN classification, validation, and XML generation. You or your authorized representative submit the final files to EUDAMED. We're the data preparation layer, upstream of submission.
What format does our data need to be in?
Any tabular format: Excel (.xlsx), CSV, or similar ERP exports. Column names can be in any language. Our AI handles the mapping to EUDAMED's 95-field schema.
What's a Registration Decision Record (RDR)?
The RDR is a 4-page PDF documenting every AI suggestion, every human override, and the reason for each decision. It's designed for your QMS binder — hash-chained and tamper-evident, aligned with ISO 13485 documentation requirements.
How does the Glass-box AI work?
Every AI suggestion comes with a confidence score: Green (high confidence, auto-approvable), Yellow (moderate — review suggested), or Red (low/missing — manual entry required). You see alternatives, can override with a logged reason, and own every decision. Co-pilot, not autopilot.
What's the difference between the Sprint and self-serve?
The Sprint is done-with-you: our expert processes your data and reviews Yellow/Red items. Self-serve gives you the same pipeline through a web upload wizard — you review everything yourself. Same quality, different level of hand-holding.
Can EUDAMate handle legacy devices (MDD/AIMDD/IVDD)?
Yes. Legacy device support is a core focus — the November 2026 deadline requires all legacy devices to be registered. Our pipeline handles MDR, IVDR, MDD, AIMDD, and IVDD device types.
How is this different from tracekey or EudaMed+?
Those tools handle the upload to EUDAMED. They require clean, structured data. EUDAMate is the step before — we take your messy source data and prepare it for those tools (or for direct DTX upload). We're complementary, not competitive.

Get your free EUDAMED readiness report

Upload your device spreadsheet — we run 50+ EUDAMED validation rules and show you exactly what's missing, miscoded, or will be rejected on submission. No cost, no commitment.