1. Agreement
These Terms of Service (the “Terms”) form a binding agreement between you (the “Customer,” “you”) and Stalwart Consulting Ltd, a Hong Kong limited liability company operating the EUDAPrep service (referred to in these Terms as “EUDAPrep,” “we,” or “our”). By creating an account, accessing, or using the EUDAPrep web application at app.eudaprep.com, you accept these Terms in full. If you do not accept these Terms, do not use the service.
These Terms incorporate by reference our Privacy Policy and, where applicable, our Data Processing Agreement (DPA). If you are using EUDAPrep on behalf of an organisation, you represent that you are authorised to bind that organisation to these Terms.
2. The service
EUDAPrep is a document-processing and XML-generation tool for medical-device companies and regulatory consultants preparing submissions to the EU Commission’s EUDAMED database. The service:
- Reads documents the customer uploads (instructions for use, labels, certificates, safety data sheets);
- Extracts regulatory data and suggests mappings to verified EUDAMED codes drawn from the EC’s published reference data;
- Validates the resulting XML against the EUDAMED XSD schema and a deterministic subset of the published business rules;
- Generates a downloadable XML file for bulk upload via EUDAMED’s own portal.
EUDAPrep does not transmit data to EUDAMED on the customer’s behalf. The customer downloads the XML and uploads it through the European Commission’s EUDAMED interface, where the Commission’s own validation runs before final acceptance.
EUDAPrep is a software tool, not a regulatory consultancy or a regulated service. Suggestions produced by EUDAPrep are aids for human review and do not constitute regulatory advice.
3. Eligibility and accounts
EUDAPrep is offered to businesses preparing EUDAMED registrations. By registering for an account, you confirm that you are at least 18 years old and that you are creating the account for legitimate business purposes.
You are responsible for the security of your account credentials, for the activity that occurs under your account, and for keeping your contact email current. You must notify us promptly at support@eudaprep.com if you suspect your account has been compromised.
4. Pricing, billing, and refunds
Pre-Deadline Unlimited Access (current offer). EUDAPrep is currently offered as a one-time payment of EUR 399 granting unlimited use of the platform through 28 May 2026 23:59 UTC (the EUDAMED registration deadline under EU MDR 2017/745). The payment is non-recurring; access expires automatically at the stated date and time and does not auto-renew. Continued use of the platform after expiry requires a separate paid plan, which will be offered to existing customers before expiry.
Post-deadline subscription (future offer). EUDAPrep may also be offered as a recurring subscription. Pricing, included submission volumes, and renewal terms applicable to such subscriptions will be presented at the point of subscription. Subscriptions renew automatically at the end of each billing period unless cancelled, and may be cancelled at any time via the Customer Portal link on your dashboard.
Payment processing. Payments are processed by our payment provider (Stripe). We do not store or have access to your full payment-card data. Tax (where applicable) is calculated and presented at checkout by Stripe Tax.
Business-to-business sale. The Pre-Deadline Unlimited Access offer is sold exclusively to businesses (medical-device manufacturers, distributors, and regulatory consultants) for use in their regulatory operations. The EU Consumer Rights Directive’s 14-day right of withdrawal applies to consumers and does not apply to business-to-business sales. By accepting these Terms and identifying as a business at checkout (including by providing a VAT identification number where applicable), you confirm you are entering into this contract in your business capacity.
Refunds. Fees are non-refundable except where required by mandatory applicable law. Where any consumer-protection withdrawal right is found to apply despite the business-to-business framing above, by accepting these Terms and immediately using the service you acknowledge that the digital service is performed without delay and that the withdrawal right may be lost once the service has been performed.
Pricing changes. The Pre-Deadline Unlimited Access price is fixed for the term of the offer and applies in full once paid. For any future recurring subscription, we may change pricing on a prospective basis with at least 30 days’ notice before any change takes effect for an existing subscription. Pricing changes do not apply retroactively to current paid periods.
5. Customer responsibilities and acceptable use
You agree to:
- Provide accurate and complete information when creating your account and when uploading documents to the service;
- Review every suggestion EUDAPrep produces (extraction, code matching, translation, formatting) before including it in a submission to EUDAMED;
- Comply with applicable laws and regulations, including the EU Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) 2017/746, when preparing and submitting your registrations;
- Refrain from uploading content that infringes third-party rights, contains malware, or violates any law.
You agree not to:
- Reverse engineer, decompile, or attempt to derive the source of EUDAPrep’s code;
- Resell, sublicense, or redistribute the service without our prior written agreement;
- Use the service to attempt to circumvent the European Commission’s EUDAMED validation;
- Probe, scan, or test the vulnerability of the service or attempt to bypass authentication or authorisation controls.
6. Intellectual property
Customer data. You retain all rights to documents you upload, to the form data you enter, and to the XML output you generate using EUDAPrep. We process this data on your behalf as described in our DPA and Privacy Policy.
EUDAPrep’s service. EUDAPrep retains all right, title, and interest in the application, its code, its mapping engines, its parsed reference data, and its branding. These Terms do not transfer any intellectual-property rights in the service to you. Subject to your compliance with these Terms, we grant you a non-exclusive, non-transferable licence to access and use the service for the term of your subscription.
The official EUDAMED schemas, business rules, and code lists embedded in the service are derived from published documents of the European Commission and are used here under the terms of the EC’s reuse policy. EUDAPrep is not affiliated with or endorsed by the European Commission.
7. Disclaimers
Suggestions, not advice. EUDAPrep produces suggestions based on your documents and on the EC’s published reference data. These suggestions are not regulatory advice. The Person Responsible for Regulatory Compliance (PRRC) under MDR Article 15(3) and the manufacturer under MDR Articles 10(7), 27, 29, and 31 remain responsible for the accuracy of all data submitted to EUDAMED.
Service availability. The service is provided “as is” and “as available.” We make commercially reasonable efforts to keep the service running but do not guarantee uninterrupted availability. Scheduled maintenance, third-party service interruptions (Supabase, Stripe, Google, Vercel), and force-majeure events may affect availability.
AI-generated outputs. Some features (document text extraction, code mapping, translation, text formatting) use generative AI. AI-generated outputs may contain errors, omissions, or hallucinations. Outputs are clearly marked in the interface and require your review before being included in your submission.
8. Limitation of liability
To the maximum extent permitted by applicable law, our aggregate liability to you under these Terms — whether in contract, tort (including negligence), or otherwise — for any claim arising out of or relating to the service or these Terms is limited to the total subscription fees you paid to us in the twelve (12) months preceding the event giving rise to the claim.
We are not liable to you for: indirect, incidental, special, consequential, or punitive damages; loss of profits, revenue, or business opportunity; loss of regulatory approvals or market access; the actions of third parties (including the European Commission’s acceptance or rejection of your EUDAMED submission); or loss arising from your failure to review suggestions before including them in a submission.
Nothing in these Terms limits any liability that cannot lawfully be limited, including for fraud, fraudulent misrepresentation, gross negligence, or wilful misconduct, or for personal injury or death caused by negligence under applicable law (including the German BGB §276(3), French Article 1231-3 / faute lourde, Italian Article 1229, and the UK Unfair Contract Terms Act 1977 where applicable).
9. Indemnification
You agree to indemnify and hold us harmless from any third-party claims arising from: your breach of these Terms; your misuse of the service; the content of documents you upload (including any infringement of third-party intellectual property or privacy rights); and your submissions to EUDAMED. Our liability for your submissions to EUDAMED is governed by Section 8.
10. Term and termination
These Terms apply for the duration of your subscription and any free-trial period. You may terminate your subscription at any time as described in Section 4.
We may suspend or terminate your access to the service immediately if you breach these Terms in a way that materially harms us or another user, if we are required to do so by law, or if your account remains overdue on payment after reasonable notice. Where practicable we will give you notice and an opportunity to cure before terminating.
On termination: your access to the application ceases; we retain audit-trail records, disclaimer acknowledgements, and final XML hashes per the retention periods in our Privacy Policy; document content and form data not subject to a statutory retention obligation are deleted on instruction or after the period specified in the DPA. You may re-download previously-exported XML files for as long as your account remains active.
11. Changes to these Terms or the service
We may modify these Terms or the service from time to time. Material changes will be communicated by email and by an in-application notice at least 30 days before they take effect. Continued use of the service after the effective date of a modification constitutes acceptance of the updated Terms.
12. Governing law and disputes
These Terms are governed by the laws of Hong Kong SAR, without regard to conflict-of-laws principles. Any dispute arising out of or relating to these Terms or the service shall be subject to the exclusive jurisdiction of the courts of Hong Kong, save that consumers in the European Union retain any non-waivable right under their local consumer-protection law to bring proceedings in the courts of their place of habitual residence.
13. Miscellaneous
Entire agreement. These Terms, together with the Privacy Policy and any DPA in force between us, constitute the entire agreement between you and EUDAPrep with respect to the service.
Severability. If any provision is held unenforceable, the remaining provisions remain in full force and effect.
No waiver. Failure to enforce a provision is not a waiver of the right to enforce it later.
Assignment. You may not assign these Terms without our prior written consent. We may assign these Terms in connection with a merger, acquisition, or sale of all or substantially all of our assets, on notice to you.
Notices. Notices to us must be sent to support@eudaprep.com. Notices to you may be sent to your account email address or by an in-application notice.
14. Contact
Stalwart Consulting Ltd, Hong Kong
General enquiries: contact@eudaprep.com
Support: support@eudaprep.com
Privacy: privacy@eudaprep.com