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 a clean, validated CSV and RDR.

Get your free readiness reportSee how it works
55+ EUDAMED fields mappedMDR, IVDR, & Legacy directivesClean CSV + RDR output

Time until legacy deadline

196
days
:
05
hrs
:
03
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.

0
fields per device in EUDAMED
Most ERPs export 10-15
0
EMDN codes to classify into
Manual lookup takes hours per device
0+
validation rules before submission
One error = full rejection

From messy spreadsheet to EUDAMED-ready CSV + RDR

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 your files

Get a clean, validated CSV ready for tracekey, EudaMed+, or your in-house submission flow — plus your Registration Decision Record (RDR) for your QMS binder.

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
Yellow: Needs Review
Red: Manual Entry
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 a clean, submission-ready CSV + 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: clean 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%)

Money-back guarantee

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)✓✗✗✗
Clean CSV + RDR✓✗✗✗
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

CSV validated against the official EUDAMED field schema

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 is a data preparation tool — we have no connection to EUDAMED. We clean your ERP data, map it to the EUDAMED field schema, classify EMDN codes, and validate against 50+ business rules. The result is a clean CSV you feed into a submission tool like tracekey or EudaMed+. We're the step before submission, not submission itself.
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 need clean, structured data to work. EUDAMate is the step before: we take your messy ERP exports and produce the clean CSV those tools expect. We're complementary, not competitive.
What's the money-back guarantee?
If a submission tool rejects your CSV, or a EUDAMED submission fails, due to a field data error in our preparation, you get a full refund. No questions asked. We validate against 50+ EUDAMED business rules before delivery; a preparation error on our side is extremely unlikely, which is why we can offer this guarantee with confidence.

Learn the requirements

Plain-language guides on the specific EUDAMED requirements manufacturers get wrong most often.

November 2026 EUDAMED deadline

Who must register by November 28, 2026, what's required, and what happens if you miss it.

Read guide
EMDN classification guide

How to find the correct EMDN code for any device across the 11-category, 8,454-code taxonomy.

Read guide
GMDN to EMDN mapping

Why existing GMDN codes can't be used in EUDAMED and how to re-classify your device portfolio.

Read guide
UDI-DI grouping rules

When devices share a UDI-DI, when a new one is required, and how Basic UDI-DI works in EUDAMED.

Read guide

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.