Pre-Deadline Offer

One price. Unlimited submissions. Until the deadline.

Pay once. Run as many EUDAMED submissions as you need until 28 May 2026. No subscription, no per-device fees, no surprises.

EUDAMED registration becomes mandatory 28 May 2026. This offer covers the entire run-up to the deadline.
Pre-Deadline Unlimited
EUDAPrep Pre-Deadline Access

Unlimited EUDAMED submissions until 28 May 2026 23:59 UTC.
One-time payment. No recurring billing.

€ 399

One-time payment. EU VAT reverse-charged for EU businesses with valid VAT IDs.

  • Unlimited submissions through 28 May 2026 — register every device in your portfolio
  • All MDR risk classes (I, IIa, IIb, III) and IVDR
  • Document extraction in any EU language — PDFs, scans, Word, label images
  • Pre-export validation against 200+ EC business rules — exports blocked if anything is missing
  • Bulk-upload-ready XML aligned with EUDAMED Production Platform v2.25.3 / XSD v3.0.28
  • EU-region hosting and database (Frankfurt). 10-year audit trail retention
  • Re-download every exported XML for the lifetime of your submission, even after 28 May
  • Email support throughout the deadline period
Get Pre-Deadline Access

Sold to businesses (medical-device manufacturers, distributors, regulatory consultants). No consumer right of withdrawal applies.

After 28 May 2026, continued access requires a separate subscription at standard pricing. We will contact existing customers before the offer expires with subscription options.

What you get

Built for the deadline, not for next year

10,000+ EUDAMED codes, verified against the EC’s published reference data — no invented codes, ever.
Document extraction from PDFs (including scans), Word files, and image labels in any EU language.
Three-tier code matching: deterministic keyword → AI-assisted → flagged for review.
Pre-export validation against 200+ EC business rules — export blocks if anything is incomplete.
Submission lock + audit trail at export. Re-download free for the lifetime of the submission.
10-year retention of disclaimer ACKs and audit-trail records for legal-claims defence (GDPR Art. 17(3)(e)).
GDPR-aligned EU-region hosting for application and database (Frankfurt), under EU data-protection law.
Stripe-managed billing with EU VAT reverse-charge handling for VAT-registered EU businesses.

Pricing questions

Common questions about the offer

No cap on the number of devices, submissions, or XML exports between the day you pay and 28 May 2026 23:59 UTC. Run your entire portfolio through the platform — one device or one hundred — for the same flat fee.
Once, at sign-up, via Stripe. €399 one-time. No recurring billing, no auto-renewal. Your access ends 28 May 2026 23:59 UTC unless you separately subscribe to standard pricing afterwards.
Your unlimited access ends. Continued use of the platform requires a separate subscription at standard pricing. Re-downloading XML files you already exported remains free — you keep what you generated. We will contact you before the deadline with subscription options.
EUDAPrep is sold by Stalwart Consulting Ltd, a Hong Kong company outside the EU. EU business customers with a valid VAT ID are charged €399 net under the EU reverse-charge mechanism (Art. 196, Directive 2006/112/EC) — you self-account for VAT in your home country. Stripe collects and validates your VAT ID at checkout.
Pre-Deadline Access is sold to businesses for use in their regulatory operations. The EU consumer-rights right of withdrawal does not apply to B2B sales. Fees are non-refundable except where required by mandatory law. If you have a problem with the platform, contact us — we want to make it work.
No — and that’s deliberate. EUDAPrep generates a validated bulk-upload XML file. You upload it to EUDAMED yourself through the EC’s own interface. You stay in control of what gets submitted; we stay out of the regulated-service side of the workflow.
Yes. The code lists and validation rules are re-ingested from the EC’s published reference data when the EUDAMED platform updates. Currently aligned with EUDAMED Production Platform v2.25.3 / XSD v3.0.28 (April 2026 release).

Ready to clear the deadline?

€399 one-time. Unlimited submissions until 28 May 2026. Sign up takes a minute.

Get Pre-Deadline Access