Spreadsheets in.
EUDAMED XML out.
Your QA/RA team fills in the Excel templates. eudaflow checks each cell, then writes XML that has passed the official EUDAMED schema. You upload it yourself.
Two questions about your devices. No file and no payment details needed now. We reply within one working day.
Here to learn first? Read our EUDAMED guides.
Interactive demo: a device spreadsheet checked and turned into EUDAMED XML
Use the arrow keys to move between cells. Press Enter to edit and Enter again to save; Escape cancels.
Issues
Edit a cell or press Apply fix. Everything runs in your browser; nothing is sent. In the service itself, you correct the cells in Excel and upload the workbook again.
Example Medical GmbH is fictional. Its GTINs use GS1 prefix 952, which GS1 reserves for examples; the EMDN codes are real.3
Start with a free check of your Excel file.
Two questions about your devices, then where to write to you. We tell you how to share your file; your quote follows the check.
Prefer email? Write to info@eudaflow.pro
Three ways to register in EUDAMED.
The Commission’s tip, by number of devices.7 eudaflow prepares the files for the middle one.
EUDAMED user interface
Up to 100 devices
You enter each device by hand in EUDAMED’s forms. For a few devices it is the simplest route.
XML bulk upload
eudaflow prepares these files
100 to 1,000 devices
The data stays in the Excel templates. eudaflow checks each cell and writes the XML files, at most 300 devices per file. More devices make more files, uploaded one after the other: 1,000 make at least four, 3,000 at least ten. You upload them under Data transfer → Bulk upload.5
Machine-to-machine (M2M)
More than 1,000 devices
Your own system sends the data to EUDAMED through an eDelivery access point. Above 1,000 devices it is one option; bulk upload works there too, in more files. eudaflow does not offer M2M today; if your volume needs it, tell us.
EUDAMED bulk upload in four steps.
You prepare the data. eudaflow checks it and prepares the files. You decide when to upload.
-
Complete the template
Choose your service and legislation, then fill the Excel template. Required fields and official value lists are marked for you.
More about this step
A template per service.
Seven services, five legislations, official values as drop-downs.
-
Upload and check
eudaflow checks formats, links between sheets and applicable rules, then validates the XML against the official XSD.
More about this step
You work in the browser and install nothing. The checks and the XML run on our server.
Your workbook is deleted after the check.
The workbook is deleted when the check ends, the XML files and the report after 7 days or when you delete them. As proof of what was sent we keep the fingerprints and the EUDAMED answers you add, not the device values from your workbook. The software never sends anything to EUDAMED.
-
Fix what the report lists
Each finding points to a sheet, row and cell. Fix errors in Excel and review any warnings before downloading.
More about this step
A report that points to the cell.
Severity, sheet, cell, field and a plain message that says what to fix, for each finding. The full list exports to CSV.
Warnings, confirmed and recorded.
The download opens once you confirm the warnings. We record who confirmed them and when.
-
Upload to EUDAMED
Download the labelled XML files in the order shown. You choose the service in EUDAMED and upload the files yourself.5
More about this step
Files in upload order.
Each file names the EUDAMED service to choose. Files for the live EUDAMED follow XSD 3.0.30.
300 devices per file.
The XSD’s limit, applied for you.
EUDAMED applies its own checks after upload; passing the XSD check does not guarantee acceptance.
See an Excel-to-XML example
How rows become nested XML
One Basic UDI-DI with four UDI-DIs and one package level. The first UDI-DI travels with its Basic UDI-DI in the device file. The other three follow in a second file, uploaded once the first has been accepted. The package level nests inside the UDI-DI it contains.
Spreadsheet
1-Basic UDI-DI
9520123CBS35N43-UDI-DI
095201234500070952012345001409520123450021095201234500389-Packages
19520123450004XML files
DEVICE.POSTupload first
<device:Device xsi:type="device:MDRDeviceType"><device:MDRBasicUDI>9520123CBS35N41-Basic UDI-DI, row 2<device:MDRUDIDIData>095201234500073-UDI-DI, row 2<udidi:packages><udidi:package>195201234500049-Packages, row 2 · 10 itemsUDI_DI.POSTupload after file 1 is accepted
<device:UDIDIData>095201234500143-UDI-DI, row 3<device:UDIDIData>095201234500213-UDI-DI, row 4<device:UDIDIData>095201234500383-UDI-DI, row 5<udidi:basicUDIIdentifier>9520123CBS35N4in each, the link backEvidence from the live EUDAMED and its test environment.
MDD
device bulk upload to the live EUDAMED received a SUCCESS acknowledgement on 25 September 2026. Company and device details remain confidential.
29 of 29
service and legislation combinations accepted in EUDAMED’s test environment.6
3.0.30
is the XSD version of the live EUDAMED; every file for it is checked against that version, pinned by checksum.4
The Commission’s files are the reference.
Templates and checks are built from the XSDs, data dictionaries and business-rule documents the Commission publishes for EUDAMED. The schema files are pinned by checksum, so a changed file cannot slip in unnoticed.
Tested on every change.
More than 2,000 automated tests, the schema checks and the Commission’s sample files run on every change to the code.
Changes are recorded.
Changes to the service are logged with their reason and the evidence that they work.
Rules the schema does not check.
The XSD checks the form of a file. The checks also read what the data must agree with: the risk class against the classification rules, the certificate details a risk class needs, GS1 and HIBCC check characters, and the EUDAMED DI and ID of legacy devices, built the way the Commission specifies.
Pick how much help you want.
The price depends on how many UDI-DIs you register and how much of the work you hand over. You get a written quote within one working day. The free check comes first, and asking for a quote commits you to nothing.
-
Self-service
For QA/RA teams who know their product data and want to check it and write the XML files themselves.
- An account with an allowance for your UDI-DIs in the live EUDAMED
- Templates for all seven services, the checks and the cell-by-cell report
- XML files in upload order, each labelled with its EUDAMED service
- Answers by email
-
Guided
For teams doing their first EUDAMED bulk upload who want someone with them from the first workbook to upload day.
- Everything in Self-service
- A kickoff call in which we go through your first workbook with you
- We read the report with you until your files pass
- Someone to call on the day you upload
-
Our recommendation
Done for you
For teams short on time before 28 November.
- You send your product data as it is: an ERP export or your own spreadsheet. If it sits in another system, we can take it from there.
- We fill in the templates and ask you only for what is missing
- You get checked, upload-ready files, and we stay on a call while you upload
- If EUDAMED rejects a device we prepared, we fix it at no extra cost
We take on a limited number of these before 28 November, in the order requests arrive.
Want to see it on your own data first? Create a free account. The free allowance covers 10 UDI-DIs in EUDAMED’s test environment, and a check that finds errors does not use it up.
Authorised representative or consultancy? We price by volume across all the manufacturers you register. Ask for partner pricing
Selling in Türkiye as well? How ÜTS registration works.
EUDAMED registration deadline 28 November 2026
Devices placed on the EU market before 28 May 2026, and still being placed on it, must be registered in EUDAMED by 28 November 2026.12
On 17 September 2026, 14,049 of the 31,191 active manufacturers in EUDAMED’s public data (45%) had no device registered. The count by country, and what it does not say.
What about legacy devices?Fix errors in the cell, before you upload.
eudaflow runs these checks on every workbook before any XML is written. EUDAMED applies its own business rules after the schema check,4 so it can still reject a device that passed here.
Required fields
Every column the template marks as required, and the ones that depend on an answer: certificate details when a certificate applies, a model or a name, an end date when a device leaves the market.
You see: The sheet, row and cell of each empty field.
UDI-DI check digits
GS1 GTINs by modulo 10, HIBCC codes by their modulo 43 check character.
You see:
Invalid format for GS1 GTIN or incorrect Modulo 10 check digit.Basic UDI-DI check characters
The two check characters of a GS1 Basic UDI-DI, computed as the GS1 General Specifications define them. Letter case counts: a and A are different characters.
You see: The cell, and the correct check characters.
Leading zeros
Identifiers stored as numbers, which lose their leading zeros in Excel.
You see: The cell, and how to re-enter the code as text.
Basic UDI-DI and UDI-DI links
Every UDI-DI points to a Basic UDI-DI on sheet 1, every Basic UDI-DI has a UDI-DI, and every child row points to a row that exists.
You see: The row, the code that was not found, and the codes that do exist.
Duplicates
The same Basic UDI-DI or UDI-DI twice in one workbook.
You see:
Duplicate. First occurrence at row 7.Risk class
Classes that do not belong to the regulation, and combinations that do not fit: tissues or blood derivatives below Class III, companion diagnostics below Class C, Class I devices marked implantable.
You see: An error, or a warning where a combination is only unusual.
Certificates
Whether the risk class needs a notified body certificate, and whether its type and notified body number are given.
You see: The certificate detail that is missing.
Official value lists
Countries, languages, storage conditions, critical warnings, clinical size units and other values from the EUDAMED XSD enumerations.
You see: The value that is not on the list.
SRN format
Actor registration numbers in the form CC-TT-NNNNNNNNN.
You see: An error, or a warning that shows exactly how a short number will be sent.
Legacy devices
For MDD, AIMDD and IVDD devices: the EUDAMED DI and EUDAMED ID built the way the Commission specifies, and one UDI-DI per EUDAMED DI.
You see: The exact code the device should have.
Schema and file size
XML is written only when no errors remain, validated against the pinned EUDAMED XSD and split at 300 devices per file.
You see: Files for Bulk upload, in upload order.
Questions buyers ask.
Why not just use the EUDAMED user interface?
You can enter devices by hand in the EUDAMED user interface, and for a few devices it is the simplest route. The Commission’s own tip is the user interface for up to 100 devices, XML bulk upload for 100 to 1,000, and machine-to-machine exchange above that.7 eudaflow prepares the files for the bulk upload route.
Bulk upload or M2M?
eudaflow uses the XML bulk upload route. It writes the XML files, and you upload them in EUDAMED under Data transfer → Bulk upload.5 It does not connect to EUDAMED through an eDelivery access point. Machine-to-machine exchange is not part of the service today; if your volume needs it, tell us.
Do you store our data, and where?
Your workbook is processed on our server and deleted as soon as the check ends. The XML files and the report stay for 7 days so you can download them, then they are deleted automatically; you can also delete them at once. For ten years we keep the fingerprints (SHA-256) of the workbook and the files, who confirmed the warnings and the EUDAMED answers you add, as proof of what was sent. We do not keep the device values from your workbook. We keep your account details: name, email, company and SRN. The service runs on Railway and the website on Vercel. The software never sends anything to EUDAMED.
Which XSD version do you validate against, and what happens when it changes?
Files for the live EUDAMED are checked against EUDAMED XSD 3.0.30 and files for its test environment against 3.0.32, the versions the Commission publishes today.4 The schema files are pinned by checksum, so the service only uses files that have been reviewed. A new version goes through the same steps (new files, a new pin, the full test run) before any XML is generated against it.
What about legacy devices and the 28 November 2026 deadline?
Legacy devices under the MDD, AIMDD or IVDD that were placed on the market before 28 May 2026 and are still being placed on it must be registered by 28 November 2026, unless the corresponding MDR or IVDR device is already registered in EUDAMED.2 Devices placed on the market for the first time from 28 May 2026 must be registered before they are placed on the market.8 No registration is needed for devices no longer placed on the market by 28 May 2026 (unless a vigilance report concerns them), or for custom-made and investigational devices.9 eudaflow handles legacy devices in five of its seven services and tells you the exact EUDAMED DI each one should have.
Do you support MDR and IVDR?
Yes. eudaflow covers MDR and IVDR devices, and legacy devices under the MDD, AIMDD and IVDD. Risk classes are checked against the regulation of the template: Class I to III under the MDR, Class A to D under the IVDR.
Who uploads the files?
You upload the files yourself. The software never sends anything to EUDAMED. The output page lists the files in upload order and names the EUDAMED service to choose for each. When a file holds several devices, EUDAMED processes each one separately, so a response can mix accepted and rejected devices; you then resubmit only the rejected ones.5 If you would rather hand the upload over, one of us can do it as a user you add to your organisation in EUDAMED; say so in your quote request.
How long does it take for 1,000 UDI-DIs?
The checks and the XML take seconds: in our latest bulk test, 301 devices were validated and written in 3.5 seconds.6 Because EUDAMED accepts at most 300 devices per file, 1,000 UDI-DIs become at least four files. Most of the time goes into your data: filling in the template and fixing what the report lists.
What does it cost?
The price depends on how many UDI-DIs you register and which package you pick, so we quote after two questions about your devices. You can try the service before paying anything: a free account covers 10 UDI-DIs in EUDAMED’s test environment.
What if EUDAMED rejects a device?
EUDAMED answers for each device separately, so you fix and resend only the rejected ones.5 If we prepared the files for you (Done for you), the fix is on us, at no extra cost.
Guides
What we learned registering devices in EUDAMED, written down with the evidence.
- Test reportEUDAMED Playground test report: all error messages
- DataEUDAMED manufacturers with no device registered (2026)
- Free toolUDI check calculator: GTIN, Basic UDI-DI, EUDAMED DI
- Questions and answersEUDAMED FAQ: deadlines and what must be registered
- Questions and answersEUDAMED FAQ: Excel, XML, XSD and upload errors
- Questions and answersEUDAMED FAQ: Basic UDI-DI, UDI-DI and issuing entities
- Questions and answersEUDAMED FAQ: market information, status, EMDN, warnings
- Questions and answersEUDAMED FAQ: actors, roles and the SRN
- TürkiyeMedical device registration in Türkiye: how ÜTS works