S-01For medical device manufacturersNew service
EUDAMED UDI data preparation from your product export
Devices already on the market must be registered in the EUDAMED UDI/Device module by 28 November 2026. Most of the work is cleaning the product master data. That is the part I help with: a field map, an error list with the EUDAMED rule behind each item, and a bulk XML draft that you upload yourself.
Who it is for · Medical device manufacturers in Hungary, Austria, Slovakia and Czechia (MDR).
| Deadline | 28 November 2026 (devices already on the market) |
|---|---|
| Mandatory module | UDI/Device registration, since 28 May 2026 |
| Input | ERP / PIM / Excel product export (xlsx or csv) |
| Output | field map, error list, XSD-validated XML draft |
| Price | free check up to 5 devices, EUR 149 up to 20 devices |
| Status | New service, so far run on synthetic demo data only |
What I do not do. no regulatory or legal advice; I do not decide risk classes or EMDN codes (for EMDN only the code format is checked); I do not issue UDIs: the codes come from your issuing entity (for example GS1).
1Why now
Why now
- 1.1Since 28 May 2026 four EUDAMED modules are mandatory to use, including UDI/Device registration. European Commission, EUDAMED overview ↗
- 1.2For devices placed on the market before 28 May 2026 and still being placed on the market, the Commission timeline gives 28 November 2026 as the deadline to register the device in the UDI/Device module. Commission timeline (PDF) ↗
- 1.3The transitional rules come from Regulation (EU) 2024/1860, which amended Article 123 MDR. Regulation (EU) 2024/1860, EUR-Lex ↗
- 1.4Bulk XML upload is possible, but the XML must validate against the official EUDAMED XSDs, and the upload itself remains a manual step. EUDAMED technical documents ↗
2How it works
01
product export
xlsx or csv
02
mapping
EUDAMED data dictionary fields
03
error list
with rule IDs
04
XML draft
XSD-validated, you upload it
2.1
Send the export
You send a product export (an anonymised extract is fine). If needed, you confirm a short list of manufacturer defaults (for example, no animal tissue).
2.2
Check and map
The tool maps each column to an EUDAMED data dictionary field, reads the code lists directly from the official XSDs and runs the business rules.
2.3
Report and XML
You get the error list in English and Hungarian, the field map and an XML draft of the clean items. You upload it in EUDAMED yourself.
3Scope
What I do
- field map: which column feeds which EUDAMED field (FLD-UDID ID, XSD element), what is missing
- mandatory fields checked against the UDI Devices data dictionary, for MDR devices
- GS1 GTIN check digit (UDI-DI) and GS1 GMN check character pair (Basic UDI-DI)
- business rules with rule IDs, for example uniqueness, consistent data under one Basic UDI-DI, risk class, market countries, trade name language
- flagged fixes, for example "2a" to CLASS_IIA, GR to EL, "Magyarország" to HU
- bulk XML draft of the clean items, validated against the official XSDs
- one revision round in the full run
What I do not do
- no regulatory or legal advice
- I do not decide risk classes or EMDN codes (for EMDN only the code format is checked)
- I do not issue UDIs: the codes come from your issuing entity (for example GS1)
- I do not upload anything to EUDAMED on your behalf and do not do actor registration (SRN)
- server-side EUDAMED checks after upload cannot be run offline
- currently MDR registration data only (Basic UDI-DI and UDI-DI); IVDR, legacy devices, system and procedure packs are not covered yet
4Sample
Sample report (synthetic data)
The sample is built from an 18-row product master of a made-up manufacturer (DEMO Példa Medikai Kft.), with typical ERP column names and deliberately planted errors. The GTINs come from the GS1 restricted circulation range, so they cannot clash with real products. The report itself is in Hungarian; for your data you get it in English as well.
- 18 items, 14 errors (all from the planted error types), 2 warnings, 7 automatic fixes
- 4 clean items went into the XML draft
- XSD validation against the official EUDAMED schema (message version 3.0.30): PASS
All data is made up. Not a regulatory check, not legal advice.
5Price
Free check
EUR 0
An export of up to 5 devices, so you can judge whether it saves you time.
- field map
- error list with rule references
- short summary
Full run
EUR 149
Up to 20 devices, fixed price.
- field map and error list in English and Hungarian
- XSD-validated bulk XML draft of the clean items
- one revision round
More than 20 devices: write to me and we agree on it. No payment is taken on this site; orders are handled by email.
6FAQ
Do you have existing clients?
Not yet. This is a new service and so far it has only run on the synthetic demo catalogue above. That is why the 5-device check is free: you see the result on your own data.
What happens to the files I send?
The checking tool runs locally, calls no external service and uploads nothing. An anonymised extract is fine. On request I delete the files after the job.
Who uploads the XML?
You do, with your own EUDAMED access. I do not log in to or send anything to EUDAMED.
Which languages?
English and Hungarian. The error list is delivered in both.
7Primary sources
Deadlines and rules taken from the official sources, checked on 5 October 2026.
8Contact
Questions or orders
Write a few lines about the task to the address below. I reply with what I need from you and when it will be ready.
Misak Systems · Ottó Misák, software engineer, Hungary (EU)
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