EUDAMED mandatory deadline: 28 May 2026

Your device documents.
EUDAMED-ready
in hours, not weeks.

EUDAPrep reads your IFUs, labels, and safety data sheets, extracts the data EUDAMED needs, matches it to the right codes, and generates submission-ready files you can upload directly.

Get Early Access See How It Works

The problem

The data EUDAMED needs is buried in your documents.

60%

of the data EUDAMED requires is typically missing or unstructured in manufacturers' internal systems.

Days

to prepare a single device registration by manually cross-referencing documents against EUDAMED fields.

100s

of codes and fields to populate per device, each with conditional rules that change based on your device type.

Zero

existing tools read your source documents for you. Every other solution requires you to fill in forms manually.

How it works

Documents in.
EUDAMED submission out.

STEP 01

Upload

Drop in your IFUs, labels, declarations of conformity, safety data sheets. PDF, scanned images, or Word files. Any EU language.

STEP 02

Extract

Your documents are read automatically. Sections are identified, languages detected, and the data EUDAMED requires is pulled out and structured.

STEP 03

Match

Extracted information is matched to the correct EUDAMED codes using a three-stage process. Most matches are direct lookups. Ambiguous cases are flagged for your review.

STEP 04

Export

Review the results, approve or edit anything, then export a validated file ready for EUDAMED bulk upload. A completeness check ensures nothing is missing.

9,000+

Official EUDAMED codes covered

35

Conditional rules that adapt to your device

100%

Of codes verified against EC source data

0

Manual portal fields to type

How we handle accuracy

You stay in control. Nothing submits without your approval.

EUDAPrep automates the extraction and matching. But every suggestion is presented for your review before it becomes part of your submission. The tool does the heavy lifting. You make the decisions.

Safeguards

  • Three-stage matching. Most codes are matched by direct keyword lookup. Only ambiguous cases use intelligent matching. Every result is validated against the official EUDAMED code lists before you see it.
  • Human approval on everything. Every suggested match is flagged as Needs Review, Auto-Matched, or Approved. You confirm, edit, or reject each one. Nothing goes into the export without your sign-off.
  • Pre-export validation. Before you can download the submission file, the system checks every field against EUDAMED's rules. If anything is incorrect or missing, export is blocked until it is fixed.

What it handles

  • Full EUDAMED coverage. MDR Classes I, IIa, IIb, and III. All critical warning codes, storage and handling codes, and device classification codes. The form adapts automatically based on your device type and risk class.
  • Multi-language documents. Upload documents in any EU language. Source text is preserved alongside an English translation. Generate translations for target market languages when EUDAMED requires them.
  • Completeness checking. After processing, the system compares what it found against every mandatory field for your device. Missing data is flagged with guidance on which document typically contains it.

Before and after

What this replaces

Today

  • Open your IFU. Read every page. Figure out which parts map to which EUDAMED fields.
  • Scroll through hundreds of warning and handling codes to find the ones that apply to your device.
  • Navigate a classification tree with thousands of entries to find the right device code.
  • Type or copy-paste each value into the EUDAMED portal, field by field.
  • Hope you have not missed a required field that only applies to your specific device class.
  • Do it again for the next device. And the next.

With EUDAPrep

  • Upload your documents. The tool reads them and identifies the relevant sections automatically.
  • Warnings, handling conditions, and classifications are matched to the correct EUDAMED codes for you.
  • Device classification is suggested based on your product documentation. You confirm or adjust.
  • Download a submission-ready file for EUDAMED bulk upload. No portal data entry.
  • A completeness check flags every required field that is missing, specific to your device type.
  • Move on to the next device.

Who this is for

Anyone preparing EUDAMED registrations from product documents

Regulatory Affairs Teams

You have 20 to 500 devices to register. The documentation exists but the data needs to be extracted, structured, and mapped to EUDAMED's requirements.

PRRCs

You are responsible for ensuring every submission is complete and correct across a product portfolio. EUDAPrep's completeness checks catch what manual review misses.

Authorised Representatives

You manage EUDAMED submissions for multiple manufacturers. Process more registrations without growing your team.

Regulatory Consultants

You are serving multiple clients against the same deadline. Spend your time on expertise and advisory, not on data entry.

Questions

Common questions

Not yet. EUDAPrep generates a validated submission file that you upload to EUDAMED yourself through the bulk upload interface. You keep full control of what gets submitted. Direct submission is planned for a future release.
EUDAPrep uses a three-stage matching process. The majority of matches are direct keyword lookups against the complete official EUDAMED code lists. Ambiguous cases use intelligent matching, but are always flagged for your review. Every suggested code is verified against the official source before you see it. Nothing is invented or guessed.
MDR Classes I, IIa, IIb, and III are fully supported. IVDR support is partial and expanding. Legacy devices under MDD, AIMDD, and IVDD are on the near-term roadmap.
PDF (including scanned documents), images of labels and packaging, Word files, and plain text. Documents in any EU language are supported with automatic language detection and translation.
Pricing is per-device with monthly subscription tiers based on volume. Significantly less than consultant fees, which typically run EUR 50 to 200 per device. Detailed pricing will be published when general access opens.
Yes. The code lists and validation rules are updated when the European Commission publishes new versions of the EUDAMED platform. Currently aligned with the December 2025 production release.

The deadline is fixed.
Your preparation time is not.

28 May 2026. EUDAPrep is onboarding early users now. If you are preparing device registrations from product documents, get on the list.

Request Early Access

We will respond within 48 hours to schedule a walkthrough.