EUDAMED registration pricing, for manufacturers or RA consultants.
Two ways to buy. Same product underneath. Sprint is a one-time, per-device purchase for manufacturers preparing their portfolio. Subscription is monthly or annual for RA consultants handling EUDAMED across multiple clients.
One-time. No subscription, no expiry.
For medical-device manufacturers preparing their portfolio for the EUDAMED November 2026 deadline. Pay per device with a €549 minimum — buy exactly the devices you have. Need more later? Top up anytime; your volume pricing carries across purchases.
- Document ingestion (IFUs, labels, safety data sheets, technical files)
- Automated extraction of EUDAMED-required fields
- Deterministic validation against EC business rules and XSD schema
- EMDN and code mapping
- Validated XML export ready for EUDAMED bulk upload
- Audit trail export per submission
Type your device count. The total updates live.
Monthly or annual. Pick a tier.
For RA consultants handling EUDAMED registrations across multiple clients. Each submission is one device's record through the full EUDAPrep pipeline. Submissions reset monthly.
- Document ingestion plus automated extraction
- Deterministic validation against EC business rules and XSD schema
- EMDN and code mapping
- Validated XML export · audit trail per submission
- Submissions reset monthly · unused submissions don't roll over
- Overage billed at end of cycle at the tier's overage rate
Per submission over the tier cap, billed at end of cycle.
- Multi-seat with per-user audit trail
- SSO integration
- White-label output · your firm's name on exports
- API access for programmatic submission
- Custom submission limits
Subscription tiers are for multi-client consultancies and consultants. If you're a manufacturer registering your own devices, Sprint is priced for your situation.
Before you buy.
What if I have more than 100 devices?
Contact us for a custom quote. Pricing scales below €99 per device at higher volumes.
Can I switch between Sprint and Subscription?
Yes. Sprint is a one-time purchase; Subscription is a recurring plan. Buy whichever fits the current job. Sprint customers don't auto-convert to Subscription.
What happens if I exceed my Subscription submission cap?
Overage submissions are billed at the tier's overage rate at end of billing cycle. Solo €25 · Agency €18 · Firm €12 per overage submission.
Can I upgrade or downgrade my Subscription tier?
Yes, through the customer portal. Changes apply at the next billing cycle.
When does the annual discount apply?
Annual billing is 20% off the monthly rate, billed once at sign-up and once per renewal year. Mid-year switches prorate.
What about VAT?
EU B2B reverse-charge applies for valid VAT-registered buyers. Stripe handles the math at checkout.
What's included in an audit trail?
Per submission: source document SHA-256, extracted values, mapped codes, validation results, final XML output. PRRC sign-off attaches to this record.
What if I'm a single-company manufacturer with many devices?
Sprint is priced for your situation. Subscription tiers are for consultants serving multiple clients. See Sprint pricing.
Is there a refund policy?
If a submission fails to upload due to a EUDAPrep-side preparation error, the credit is refunded to your account. For anything else, contact us and we'll sort it out.
What happens to my data if I cancel?
Your account stays accessible read-only for 30 days after cancellation, so you can export everything you need. Audit-trail records are retained per the documented data-retention policy.