Your EUDAMED dataisn't ready.↳ is

Device data from different places. 8,454 EMDN codes to choose from. A stack of CE certificates to dig through.

EUDAMate does that work. You get a clean CSV and a documented RDR.

MDCG guidance updated February · Reg. 2024/1860 changed IVDR transition gates · EUDAMED schema v3.0.28

Every schema revision and guidance update, monitored and applied continuously.

Start your project →See how it works

MDR · IVDR · MDD · IVDD · Full money-back guarantee

EMDN Classification
DeviceEMDN CodeStatus
Surgical scissors06-01-04-01-01HIGH
Knee implant06-03-04-01-00REVIEW
Diagnostic strip05-02-03-00-00CONFIRM
Suture06-01-08-01-00HIGH
4 devices3 HIGH1 REVIEW68 fields mapped
How it works

Four steps from chaos to compliance.

01Your data, as-is

Upload

Export your device list from SAP, Excel, or your ERP. Drop the file. No template, no reformatting required.

Accepts CSV, XLSX, ODS · up to 50,000 rows
devices_export_Q2.xlsx
product_type
article_desc
ref_number
item_cat
Surgical scissors
General purpose
SC-201
Instruments
Knee implant
Tibial plate, L
KI-4401
Implants
Diagnostic strip
Glucose test
DS-0031
IVD
Suture
Absorbable 3/0
SU-702
Consumables
4 rows detected · ready to map
0268 fields, auto-mapped

Map

AI reads your column names and maps them to 68 EUDAMED fields. Every match gets a confidence score.

Review mismatches before proceeding
Your columnEUDAMED field
product_type
deviceType
97%
article_desc
deviceDescription
91%
ref_number
manufacturerDeviceId
88%
item_category
nomenclatureCode
74%
material_type
specialDeviceType
62%
038,454 EMDN leaf codes

Classify

Each device is classified against the full EMDN tree. Ambiguous entries are flagged for your review. Nothing is silently guessed.

Ambiguous entries flagged for human review
EMDN classification result
Surgical scissors
06-01-04-01-01
General surgical scissors
HIGH
Knee implant
06-03-04-01-00
Knee prosthesis
REVIEW
Suture
06-01-08-01-00
Absorbable suture
HIGH
From 8,454 EMDN leaf codes
04Submission-ready output

Deliver

Clean CSV + hash-chained RDR PDF. Validated against 50+ MDR/IVDR rules. Compatible with EUDAMED submission portals or direct EUDAMED import.

Full audit trail, legally defensible
CSV
devices_EUDAMED_clean.csv
68 fields · validated · submission-ready
PDF
readiness_report_RDR.pdf
Hash-chained audit trail · MDR Annex II
Compatible with submission portals · EUDAMED direct
Glass-box AI

Every decision is visible.

Co-pilot, not autopilot. EUDAMate shows you exactly why each EMDN code was assigned, and flags what needs your review.

DeviceYour ColumnEMDN CodeConfidenceReasoning
Surgical scissorsproduct_type06-01-04-01-01
HIGH
“Matched: general surgical instrument + scissors morphology”
Knee implantarticle_desc06-03-04-01-00
REVIEW
“Implantable orthopedic, verify fixation method”
Diagnostic stripproduct_name05-02-03-00-00
CONFIRM
“In vitro diagnostic, subclass ambiguous without IVD indication”
Suturematerial_type06-01-08-01-00
HIGH
“Wound closure + material field: absorbable”
Drapeitem_category06-07-01-01-00
HIGH
“Surgical barrier, draping. Clear category match.”
68 of the 95+ EUDAMED fields, mapped per device
Full audit trail in your RDR PDF
What you receive

Your readiness report,
in minutes.

app.eudamate.eu/readiness-report
EUDAMate EUDAMED Readiness Report
Free analysis
No template required
95-field gap report
PDF ready for submission team
24-hour turnaround
PRICING

Find your model.

Transparent pricing. You see every number before you commit.

SPRINT
ONE-TIMEREADY IN MINUTES

Sprint

Data preparation for EUDAMED. Your raw exports in. Clean CSV + RDR out.

1–3 devices€1,250
4–10 devices€2,500
11–50 devices€200 per device
51–100 devices€175 per device
100+ devicesGet a quote

Ready to review in minutes. Most teams complete review in a day.

INCLUDED

68 EUDAMED fields mapped per device
EMDN classification across 8,454 codes
MDR and IVDR validation, 50+ rules
Registration Decision Record included
EXPERT REVIEWADD-ON

An expert reviews every field decision before delivery. Add it at checkout.

Expert verification within 1–2 business days

€125 per device

Full refund if the submission tool rejects your CSV due to a preparation error. No questions asked.

Delivery guarantee

Registry CareSUBSCRIPTION

Keeps your EUDAMED records current after the Sprint. Regulations change, certificates renew — no per-event fees.

Micro≤3 devices
€59/mo
Starter≤10 devices
€149/mo
Standard≤50 devices
€279/mo
Scale≤100 devices
€499/mo

Offered after delivery. Save ~20% with annual billing.

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. Sprint data deleted after delivery. Subscription accounts control their own retention.

EUDAMate works inside your workflow.

Most manufacturers run the Sprint once or a few times a year. The subscription plan is built for a different workflow: multiple clients, continuous submissions, and output that carries your firm's name instead of ours. Multi-client dashboard, shared EMDN classification history, white-label RDR. Different economics for a different job.

FOR RA CONSULTANTS

Bill for your judgment. We handle the labor.

Column mapping, EMDN code lookup, 62-field validation: EUDAMate handles all of it in minutes. Your clients get a clean, documented output. The time you recover goes back to the regulatory strategy, risk assessment, and notified body liaison that warrants your fee.

Every submission includes a hash-chained Registration Decision Record
EMDN classification across 8,454 codes, automated and reviewable
Validation errors caught before your client touches the portal
Output goes out under your client's name, not ours

Token pricing, no monthly commitment. Full breakdown in the pricing section.

FOR REGULATORY PLATFORMS

The data layer your tool is missing.

Your tool handles the portal submission. EUDAMate handles everything before that: mapping raw device exports to 62 EUDAMED fields, running 50+ validation rules, classifying EMDN codes, generating a Registration Decision Record. Integrate once as a pre-step. Your users arrive with submission-ready data rather than the raw exports they started from.

Structured CSV output your tool already understands
Full audit trail per submission: hash-chained RDR included
Rejection rates drop before they reach your interface
API-first: documented, testable, production-ready
Integration options, white-label output, and API access by arrangement.Get in touch →

Under the hood

The accuracy details your RA team will ask for.

Built to pass RA scrutiny, not just checkbox compliance. Every technical decision is traceable in your RDR.

SCHEMA

Validates output against EUDAMED v3.0.28 XSD before export.

CERTIFICATES

40-NB NANDO registry integration for automatic certificate SRN resolution.

DEADLINES

IVDR Class C/D NB application deadline warnings per Regulation 2024/1860.

2024/1860

Prior NB refusal disclosure field, a new requirement under Regulation 2024/1860.

LEGACY UDI

Correct EUDAMED DI vs Basic UDI-DI distinction for legacy MDD/AIMDD/IVDD devices.

RULES

50+ MDR/IVDR/legacy business rules validated before delivering the clean CSV.

RESOURCES

Know the deadline.
Know the codes.

MDR · IVDR

May 28, 2026

MDR and IVDR devices entering the EU market on or after May 28 need a valid EUDAMED record in place.
EU 2025/2371

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MDD · AIMDD · IVDD

November 27, 2026

Devices placed under MDD, AIMDD, or IVDD need to appear in EUDAMED by November 27. This covers everything already on the EU market.

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DEADLINE

November 2026 EUDAMED deadline

Who must register by November 27, 2026, what's required, and what happens if you miss it.

Read guideCLASSIFICATION

EMDN classification guide

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

Read guideCLASSIFICATION

GMDN to EMDN mapping

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

Read guideUDI

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

FAQ

Questions.

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 your submission portal or tool. We're the step before submission, not submission itself.

Any tabular format: Excel (.xlsx), CSV, or similar ERP exports. Column names can be in any language: German, French, Turkish, English. Our AI handles the mapping to 62 EUDAMED fields.

The RDR is a 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.

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.

The Sprint is done-with-you: our expert processes your data and reviews Yellow and 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.

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 without any manual re-classification of your existing portfolio.

Submission portals 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 portals expect. We're complementary to your existing submission workflow, not a replacement.

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.

Legacy Device Deadline
--days
--:--:--remaining

Every day closer is a day less to prepare.

There's a version of November where your submission is already done and waiting. Let's build that one.

Start your project →Get your free readiness report

No credit card required. Start in minutes.