28 Nov 2026EUDAMED registration deadline

Spreadsheets in.
EUDAMED XML out.

eudaflow checks the UDI and device data in your Excel templates cell by cell and shows every error before upload day. Then it writes XML that has passed the official EUDAMED schema, and you upload it yourself.

Interactive demo: a device spreadsheet checked and turned into EUDAMED XML

example-medical_MDR_new-device.xlsx

Checking…

Use the arrow keys to move between cells. Press Enter to edit and Enter again to save; Escape cancels.

XSD 3.0.30

Issues

    This demo reads it in your browser; nothing is uploaded. The service itself works with the Excel templates.

    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.

    Open full screen

    Example Medical GmbH is fictional. Its GTINs use GS1 prefix 952, which GS1 reserves for examples; the EMDN codes are real.3

    From template to upload in four steps.

    You prepare the data. eudaflow checks it and prepares the files. You decide when to upload.

    1. Complete the template

      Choose your service and legislation, then fill the Excel template. Required fields and official value lists are marked for you.

    2. Upload and check

      eudaflow checks formats, links between sheets and applicable rules, then validates the XML against the official XSD.

    3. Fix what the report lists

      Each finding points to a sheet, row and cell. Fix errors in Excel and review any warnings before downloading.

    4. Upload to EUDAMED

      Download the labelled XML files in the order shown. You choose the service in EUDAMED and upload the files yourself.5

    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

    29520123CBS35N4Class IIb · CBS-35

    3-UDI-DI

    209520123450007CBS-35-12
    309520123450014CBS-35-14
    409520123450021CBS-35-16
    509520123450038CBS-35-18

    9-Packages

    21952012345000410 × 09520123450007

    XML 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 items

    UDI_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 back

    Evidence from EUDAMED Production and Playground.

    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.

    1. Self-service

      For teams who know their product data and want to do the work themselves.

      • An account with an allowance for your UDI-DIs in EUDAMED production
      • 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

      Price on request

      Get a quote for this
    2. Our recommendation

      Guided

      For teams registering devices in EUDAMED for the first time.

      • 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

      Price on request

      Get a quote for this
    3. 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
      • 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.

      Price on request

      Get a quote for this

    Want to see it on your own data first? Create a free account. The Playground allowance covers 10 UDI-DIs, 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? For registration in ÜTS, Türkiye’s national product tracking system, we prepare your documents and device file and check them before upload. Your own staff confirms and signs the application. How ÜTS registration works. Get a quote for ÜTS

    Time left to register devices already on the market.

    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.

    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.

    Templates, checks, report and XML in one place.

    You work in the browser and install nothing. The checks and the XML run on our server, and the workbook is deleted when the check ends.

    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.

    Files in upload order.

    Each file names the EUDAMED service to choose. Production files follow XSD 3.0.30.

    300 devices per file.

    The XSD’s limit, applied for you.

    A template per service.

    Seven services, five legislations, official values as drop-downs.

    Warnings, confirmed and recorded.

    The download opens once you confirm the warnings. We record who confirmed them and when.

    Legacy devices, with the right EUDAMED DI.

    For MDD, AIMDD and IVDD devices the report states the exact EUDAMED DI and EUDAMED ID to use.

    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. We never send anything to EUDAMED.

    Built on the Commission’s own files.

    Questions buyers ask.

    Why not just use the EUDAMED user interface?

    You can, 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?

    Bulk upload. eudaflow 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, so there is no machine-to-machine exchange.

    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. We never send anything to EUDAMED.

    Which XSD version do you validate against, and what happens when it changes?

    Production files are checked against EUDAMED XSD 3.0.30 and Playground files 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, and the legacy directives 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 do. eudaflow 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

    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?

    It depends on how many UDI-DIs you register and which package you pick, so we quote after two questions (the form below). You can try the service before paying anything: a free account covers 10 UDI-DIs in the Playground.

    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.

    Get a quote for your devices.

    Two questions about your devices, then where to send the quote. If you like, we check your file for free first.

    Step 1 of 2: your devices

    About how many UDI-DIs do you need to register?
    How much of the work should we take on?