Terms of Service

EUDAMate is a data preparation service. It takes your existing device records, maps them to EUDAMED field requirements, validates them against MDR/IVDR rules, and produces a clean CSV and Registration Decision Record (RDR) your regulatory affairs team can use when submitting to EUDAMED.

EUDAMate does not submit data to EUDAMED, register actors, or interact with the EUDAMED portal in any way. Your RA team is responsible for the actual portal submission. EUDAMate's output is a preparation artifact, not a submission.

You must be at least 18 years old and have authority to enter into contracts on behalf of your organisation to use EUDAMate. By using the service, you confirm both.

• You are responsible for the accuracy of the source data you upload. EUDAMate maps and validates what you provide; it cannot correct fundamentally wrong source information.
• You are responsible for reviewing the output before your RA team uses it for any regulatory purpose.
• You must not upload data you do not have the right to process, including third-party confidential information.
• You must not use EUDAMate to prepare data for devices that are not lawfully placed on the EU market.

EUDAMate automates data preparation. It is not a substitute for regulatory affairs expertise. The output is a best-effort preparation based on publicly available EUDAMED field requirements and MDR/IVDR rules. For complex classifications, borderline devices, or regulatory strategy, consult a qualified regulatory affairs professional.

The Expert Review add-on connects you with a certified engineer who reviews your output. That review covers the accuracy of the prepared data, not broader regulatory strategy or notified body interaction.

• Payments are processed by Stripe. By purchasing, you agree to Stripe's terms in addition to these.
• Sprint (one-time) purchases: refundable within 48 hours of purchase if the report has not been downloaded. Once downloaded, the fee is non-refundable.
• Subscriptions (Registry Care, Consultant Partner): billed monthly or annually. You may cancel at any time; cancellation takes effect at the end of the current billing period. No partial refunds for unused periods.
• Consultant tokens: non-refundable once purchased.

The EUDAMate platform, interface, guides, and underlying pipeline logic are our intellectual property. You retain full ownership of the data you upload and the output files generated from it.

You may not:

• Reverse-engineer, scrape, or otherwise extract the EUDAMate pipeline logic or EMDN classification system
• Resell access to the platform without a Consultant Partner agreement
• Use the service in a way that violates applicable EU or national law
• Attempt to circumvent authentication or access controls

We aim for high availability but do not guarantee uninterrupted access. We may perform maintenance, updates, or experience outages. We will communicate planned maintenance in advance where possible.

To the maximum extent permitted by law, EUDAMate's liability for any claim arising from use of the service is limited to the amount you paid in the 3 months preceding the claim.

We are not liable for indirect, incidental, or consequential damages including loss of revenue, loss of data, or regulatory penalties arising from reliance on EUDAMate output without independent RA review.

These terms are governed by the laws of Germany. Any disputes shall be subject to the exclusive jurisdiction of the courts of Germany, without prejudice to your rights as a consumer under your local law.

We will notify you of material changes by email at least 14 days before they take effect. Continued use of the service after that date constitutes acceptance of the updated terms.

Questions about these terms: ege@eudamate.eu