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EUDAMED data preparation

From your Excel files
to checked XML.

Detect issues, correct each row, then generate the XML file — and travel the same road backwards when EUDAMED answers.

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Templates tailored to your sources Traceable controls XML ready for Bulk Upload
EUDAMED answers in XML. We hand it back to you in Excel.
Product preview
XLSXFichier_Transfert_MDR.xlsx
Structured data
Basic UDI-DIClassSRNStatus
BASIC-UDI-EXEMPLE-01IIaFR-MF-[…]Complete
BASIC-UDI-EXEMPLE-02IIbDE-MF-[…]Review
BASIC-UDI-EXEMPLE-03IIIIT-MF-[…]Complete

The team completes a readable template; every row remains identifiable during checks.

XMLDevice_Export.xml
File ready to download 
<Device>
  <BasicUDI>BASIC-UDI-EXEMPLE-01</BasicUDI>
  <RiskClass>IIa</RiskClass>
  <ActorSRN>FR-MF-[…]</ActorSRN>
  <Status>ready</Status>
</Device>
Check report retainedThe XML and findings remain linked to the generation.
7

EUDAMED modules covered

MDR, IVDR, Legacy, Procedure Packs, vigilance, updates and Pull Requests.

30

Generation scenarios

Creation, linking, updating and extraction according to the selected operation.

51

Validation rules

Each one identified, dated and tied to its source.

300

Entities per XML file

Cap set by the EUDAMED schema: beyond it, batching is automatic.

Regulatory data begins in teams' day-to-day work.

The real workflow

Behind every Excel row is a device, a team and a deadline.

One workflow: prepare, detect, correct, generate.

  1. 01Your team stays in Excel
  2. 02Issues become actionable
  3. 03XML is generated with its evidence

The problem

Demanding data, methods that don't always keep up

Every manual step increases the risk of error.

Regulatory professional preparing medical-device data on a laptop
Real data, real teams and deadlines that leave no room for silent errors.

  1. Strict structures

    Dozens of fields, many conditional: what is required here depends on what was entered there.

  2. Manual re-entry

    Copying the same data from one file to another multiplies inconsistencies — and the time spent hunting them down.

  3. Errors that are hard to interpret

    An XML rejection rarely points back to the row and column of the source file. Diagnosis takes longer than the fix.

  4. M2M is not always the answer

    A full machine-to-machine integration requires budget, integration work and technical resources that not every organisation has — or has yet.

  5. The need for a middle path

    Between fully manual entry and large integrations, a structured, controlled, affordable approach is missing.

Individually packaged sterile medical devices
Source Every device carries data to register.
Check Every issue is located.
Data flow connecting a table to a medical-device system
Output Checked Excel, traceable XML.

Why Excel

Start from the tool your teams already master

Keep Excel. Let's EUDAMED structures, checks and traces the workflow.

  • A familiar environment: nobody learns a new tool to prepare their data.
  • Progressive preparation: the file advances at the team's pace, not a data-entry session's.
  • Collaborative work: templates are shared, reviewed and corrected together.
  • Your internal review processes stay in place — the platform adds to them, it does not replace them.
  • Templates structured around the expected data, checked before any generation.
  • Corrections happen in the source file — where your data already lives.
XLSX CONTRÔLE XML

The online platform

A web platform to prepare, check and generate your EUDAMED files.

Accessible from your browser, with templates and checks centralized in one place. You choose the EUDAMED module and operation, use the matching template, and the platform applies the same checks before every generation.

Request access →

Complementary option

An application installed on your workstation, if needed.

For organizations with local execution constraints, Let's EUDAMED is also available as an installed application, using the same control engine as the online platform.

Particularly relevant when:

  • IT policies do not allow the use of an online service
  • data must remain on a workstation or internal infrastructure
  • usage is occasional, without depending on a permanent connection
Discover the desktop application →

The workflow

From Excel to XML, with checks at the right stage.

Prepare, check, correct, generate and download.

01

Download the template

A structured Excel template, matched to the chosen operation.

02

Prepare the data

In Excel, at your pace, with your review processes.

03

Import

Select the EUDAMED operation and upload the matching Excel template.

04

Analyze

Required fields, formats, dictionaries and dependencies are checked row by row.

05

Correct

Each issue identifies the row, field, problem and expected action.

06

Generate

Export the XML and, where needed, the automatically split batches.

07

Download the results

The XML file and the check report, kept in your history.

Validation results
SeverityRowFieldCheck
Error27Risk_ClassMissing or unauthorized value
Error89Package_DICode_2Status and quantity required
Warning112Manufacturer_SRNContact details will be ignored
Valid247XMLStructure ready to generate

Actionable validation

An error should never come as a surprise at submission time.

The platform separates blocking errors from business warnings. It checks empty cells, allowed values and conditional combinations.

  • ✓
    Required fields and formats Checks are applied only when the data or condition requires them. R-001 · R-007
  • ✓
    Formats and allowed values Each column is checked against its format and expected value list. R-003 · R-018
  • ✓
    Value dictionaries Languages, classes, countries, warnings, storage conditions and other lists. R-004
  • ✓
    Conditional rules A field that is required “depending on the case” is checked in its real context, row by row. R-008 · R-015
  • ✓
    Cross-field consistency Packages, SRNs, manufacturers, markets and dependent fields. R-026 · R-030 · R-031
  • ✓
    Schema structure and version The generated XML is validated against the selected XSD schema, whose version is displayed. R-017 · R-023 · R-024
  • ✓
    Duplicate identifiers The same UDI-DI repeated in the file is flagged as a warning; a repeated Basic UDI-DI, on the other hand, is normal. R-019
  • ✓
    Exportable Excel report A compliance record that can be shared with quality and regulatory teams.

What separates us from a converter

51 validation rules, each identified, dated and sourced.

An issue with no rule to cite is not a check. Every issue in your report carries the identifier of the rule that detected it, and that identifier is never reassigned: an archived report stays readable years later.

28 of these 51 rules do not come from the initial core: they were born from a conformity audit against the official schema, from internal qualification, or from a client deployment. The library grows with every difficult case.

See all 51 checks, named

The return path

EUDAMED answers in XML. We hand it back to you in Excel.

Your devices are already registered in EUDAMED? Drop the registry's response here: it becomes an Excel template again, ready to be corrected and resubmitted.

The values come from EUDAMED itself, so non-updatable fields are echoed unchanged — which avoids the “… is not updatable” rejection on update.

  1. Request your data Generate a request with the “Pull Request” module and submit it to EUDAMED.
  2. Collect the response EUDAMED returns an XML file containing your devices.
  3. Drop it here We turn it back into an Excel template: one row per device, with the usual lists and checks.
  4. Correct and resubmit Change what needs changing, then generate the update from the matching module.

Functional coverage

One platform for very different EUDAMED workflows.

One Excel template, a rule set and an XML file per operation.

Coverage tracked and maintained

Changes to the supported structures, XSD versions and EUDAMED rules are tracked so the relevant templates and checks can be adapted.

You work with the centralized templates available on the platform, without having to rebuild your files yourself with every supported change.

Supported XSD version3.0.30

Classic Medical Devices (MDR Regulation)

Creation and update of UDI-DI / Basic UDI for classic medical devices.

4 operations available in this module

  • Full Import (Creation) Use this for the very first declaration of a device: creates the Basic UDI-DI (parent) AND its first UDI-DI (child) in one operation.
    Available
  • Import linked to an existing Basic UDI Use this when the Basic UDI-DI (parent) already exists in EUDAMED and you're adding a new variant (new UDI-DI) to that same model — e.g. a new size in the same range.
    Available
  • Child Update (UDI-DI) To correct or complete the information of an already-registered UDI-DI (status, packaging, warnings...) without touching the parent Basic UDI-DI.
    Available
  • Parent Update (Basic UDI) To correct or complete the information shared by the whole device family (risk class, certificates, original designer...).
    Available

Procedure Packs and Systems (MDR)

Management of procedure packs and systems.

4 operations available in this module

  • Full Import (Creation) First declaration of a procedure pack: creates the Basic UDI-DI and its first UDI-DI at once.
    Available
  • Import linked to an existing Basic UDI Adds a new UDI-DI (variant) to a procedure pack whose Basic UDI-DI already exists.
    Available
  • Child Update (UDI-DI) Corrects the information of an already-registered variant (UDI-DI).
    Available
  • Parent Update (Basic UDI) Corrects the information shared by the whole procedure pack range (Basic UDI-DI).
    Available

In Vitro Diagnostic Devices (IVDR Regulation)

Creation and update of in vitro diagnostic devices.

4 operations available in this module

  • Full Import (Creation) First declaration of an IVD device: creates the Basic UDI-DI and its first UDI-DI at once.
    Available
  • Import linked to an existing Basic UDI Adds a new variant (UDI-DI) to an IVD device whose Basic UDI-DI already exists.
    Available
  • Child Update (UDI-DI) Corrects the information of an already-registered IVD variant (UDI-DI).
    Available
  • Parent Update (Basic UDI) Corrects the information shared by the whole IVD range (risk class, certificates...).
    Available

Legacy Devices (MDD / AIMDD / IVDD Directives)

Devices under the former MDD / AIMDD / IVDD directives.

6 operations available in this module

  • Legacy MDD/AIMDD Import First declaration of a &laquo;legacy&raquo; medical device under the MDD or AIMDD directive.
    Available
  • MDD/AIMDD Child Update Corrects the information of an already-registered Legacy MDD/AIMDD UDI-DI.
    Available
  • MDD/AIMDD Parent Update Corrects the information shared by the Legacy MDD/AIMDD range (Basic UDI-DI).
    Available
  • Legacy IVDD Import First declaration of a &laquo;legacy&raquo; IVD device under the IVDD directive.
    Available
  • IVDD Child Update Corrects the information of an already-registered Legacy IVDD UDI-DI.
    Available
  • IVDD Parent Update Corrects the information shared by the Legacy IVDD range (Basic UDI-DI).
    Available

Specific Updates (PUT Operations)

Adding market information, packaging or original designer details.

3 operations available in this module

  • Packaging Hierarchy Declares or updates the packaging levels of a UDI-DI (box, carton, pallet...).
    Available
  • Original Designer (Product Designer) Provides the device's original designer when it differs from the declaring manufacturer (with or without an SRN code).
    Available
  • Market Information Declares the countries of commercialisation, the first placed-on-the-market date and, if applicable, the withdrawal date.
    Available

Vigilance and Post-Market Surveillance Reports (VIG / MSU Module)

Reporting incidents, corrective actions, safety notices and periodic reports to the authorities.

5 operations available in this module

  • MIR (Manufacturer Incident Report) Reports a single incident (serious or potentially serious) involving a device already on the market. The first link in the vigilance chain: file it without delay after becoming aware of the incident.
    Available
  • FSCA (Field Safety Corrective Action) Documents a corrective action decided by the manufacturer on devices already distributed (recall, update, instruction). Usually follows one or more MIRs, or the manufacturer's own internal analysis.
    Available
  • FSN (Field Safety Notice) The notice actually communicated to users/customers to inform them of an FSCA. Reference the notice PDF here (name + path in the attached archive) per affected country.
    Available
  • PSUR (Periodic Safety Update Report) Periodic safety and performance summary for a device (or family), independent of any specific incident. Frequency to be determined by your device's risk class.
    Available
  • MTR (Trend Report) Flags a statistically significant increase in the frequency/severity of non-serious incidents or expected side-effects, detected by the manufacturer through post-market surveillance.
    Available

Query Templates (Pull Requests - GET Operation)

Generating download requests (certificates, actor profiles, device data).

4 operations available in this module

  • Pull Request DEVICE Queries the devices database (UDI-DI / Basic UDI-DI) using criteria such as the manufacturer's SRN, country, risk class or status.
    Available
  • Pull Request ACTOR Queries economic actor profiles (manufacturers, authorised representatives, importers) by actor code, country or actor type.
    Available
  • Pull Request SSCP Queries Summary of Safety and Clinical Performance documents by Basic UDI, certificate number or revision number.
    Available
  • Pull Request CERTIFICATE Queries certificates issued by notified bodies (by type, status, issue or expiry period).
    Available

Trust and compliance

What really matters for your EUDAMED submissions.

Product commitments

Templates and checks kept up to date
Templates and checks are tracked against the supported EUDAMED changes. When a structure, an XSD version or a validation rule evolves, the relevant tools are adapted to keep prepared and generated files consistent.
Checks before generation
Every Excel file is analyzed before generation: required fields, formats and the main consistency rules are checked. The XML file is only generated once blocking errors are corrected.
Actionable results
Every identified issue shows the row, the field concerned and the reason for the block or warning, making it easier to correct the data.
Structured functional coverage
Operations are organized by module so you can select the right process, use the matching template and apply the associated checks before generation.

Commercial commitments

Free as of today, no auto-renewal
No payment is required as of today and there is no auto-renewal. Prices are public and will apply from a date announced in advance.
Fictitious data only
Fictitious, anonymised or non-confidential data. Never patient or health data.
Controlled access
No open sign-up: every account is validated, personal, time-limited and revocable.
XSD validation ≠ EUDAMED acceptance
XSD validation attests structural conformity to the schema — never acceptance by EUDAMED nor regulatory compliance.

Understand before acting

The EUDAMED questions your teams are already asking.

Dated answers linked to official sources.

01

How do you register in EUDAMED?

Start by identifying your organisation's role. Actor registration comes before user access and, depending on the role, device registration.

Read the answer
02

How do you obtain an SRN in EUDAMED?

An SRN is obtained through an actor registration request. Following review and approval by the competent national authority, EUDAMED generates the Actor ID or SRN.

Read the answer
03

How do you prepare a device and UDI registration?

The manufacturer prepares the dataset for the device type, including UDI identifiers and required information. Data quality and consistency should be checked before submission.

Read the answer
04

What EUDAMED steps apply to a non-EU manufacturer?

To request actor registration, a non-EU manufacturer needs an active authorised representative and must provide a mandate summary with the request.

Read the answer
05

Which EUDAMED modules are mandatory in 2026?

Since 28 May 2026, four modules have been mandatory: Actor registration, UDI/Device registration, Notified Bodies & Certificates, and Market Surveillance.

Read the answer
View all EUDAMED guides
Architecture preservedYour data remains tied to its regulatory structure.

An independent approach

Your templates remain the foundation. We secure the data around them.

Each service keeps its columns, Excel format and XML structure. Checks take place before generation without changing the validated architecture.

01Your Excel templates are preserved
02Each rule is linked to the relevant columns
03Issues are explained before XML export

Let's EUDAMED is an independent tool. It does not replace internal regulatory review or the official EUDAMED portal.

Free access

Turn EUDAMED preparation into a controlled process.

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