EUDAMED & SwissDaMed M2M & Bulk Uploads

Let us take care of your EUDAMED and SwissDaMed data preparation. We convert and validate your data, create XML, and deliver it directly to the European Commission's EUDAMED via M2M or Bulk Upload.

How It Works

From Spreadsheet OR JSON to EUDAMED — We Handle Everything

Our end-to-end service covers templates, validation, XML conversion and upload — so you don't have to.

1

Prepare Your Data

Use our free MDR/IVDR spreadsheet templates OR JSON vai API to organise your device data. Templates cover Actors, Basic UDI-DI, UDI-DI, and certificates.

2

Validate & Convert

Upload your data to our Validator. We check mandatory fields, apply EC business rules, then convert validated data to XML ready for EUDAMED.

3

Upload to EUDAMED

Choose Bulk Upload (cost-effective) or M2M (fully automated). We deliver XML files directly to the European Commission's EUDAMED system.

Service 1

The Validator

Upload your populated EUDAMED spreadsheets OR JSON via API and our system prepares PDF files split into Basic UDI and UDI-DI records. Configure up to 100 UDI-DIs per PDF for easy review.

  • Background processing with email notification when complete
  • Mandatory fields highlighted if unpopulated
  • Validation against EC business rules
  • Error detection and reporting before submission
Service 2

The Converter

Our converter takes validated spreadsheet data and generates the XML files required by the European Commission. You receive both PDF records and XML files ready for manual EUDAMED Bulk Upload, Automated Uploads, and M2M.

  • Re-validates data for safety before conversion
  • Supports large volumes — thousands of devices
  • Our M2M implementation is costs effective, we do not charge extra
  • Email notification with PDF + XML zip download
Advanced Option

Machine-to-Machine (M2M) Data Exchange

Fully automated data exchange between your systems and EUDAMED via CEF eDelivery access points — no manual intervention required.

Option 1 — Your Own Access Point

  • We install, configure and manage your access point
  • PKI certificate configuration
  • Integration with your ERP/QMS systems

Option 2 — Use Our Access Point

  • Simple REST API upload to our access point
  • We validate, create the XML, and transmit to EC on your behalf
  • No M2M infrastructure needed on your side
Downloads

EUDAMED Spreadsheet Templates

Download our MDR and IVDR template packages to prepare your device data for EUDAMED. Templates are available for Actors, Devices, Regulation and Legacy devices and more.

MDR EUDAMED Templates

Complete set of MDR templates for Actors, Basic UDI-DI, UDI-DI, and Certificates. Formatted to match EC requirements.

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IVDR EUDAMED Templates

Complete set of IVDR templates for in vitro diagnostic device registrations. Pre-validated against EC business rules.

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Ready to streamline your EUDAMED uploads?

Contact our team to discuss which upload method is right for your organisation.

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